Trial Outcomes & Findings for Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer (NCT NCT03839940)

NCT ID: NCT03839940

Last Updated: 2025-01-29

Results Overview

The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 39 participants
• Primary outcome timeframe: Up to 8 weeks
• Results posted on: 2025-01-29

Participant Flow

Participant milestones

Measure	Group I (Dexamethasone) Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks. Dexamethasone: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care	Group II (Placebo) Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks. Placebo: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care
Overall Study STARTED	20	19
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Group I (Dexamethasone) Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks. Dexamethasone: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care	Group II (Placebo) Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks. Placebo: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care
Overall Study Withdrawal by Subject	3	0
Overall Study Protocol Violation	0	1
Overall Study No Post-Baseline Pain Score Data	1	1

Baseline Characteristics

Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer

Baseline characteristics by cohort

Measure	Group I (Dexamethasone) n=16 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks. Dexamethasone: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care	Group II (Placebo) n=17 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks. Placebo: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care	Total n=33 Participants Total of all reporting groups
Age, Continuous	65.3 years STANDARD_DEVIATION 10.71 • n=5 Participants	65.3 years STANDARD_DEVIATION 8.46 • n=7 Participants	65.3 years STANDARD_DEVIATION 9.46 • n=5 Participants
Age, Customized Age group · <50 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Customized Age group · 50 - 65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Customized Age group · >65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Cancer Type Breast	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Cancer Type Other	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
ECOG Performance Status 0	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
ECOG Performance Status 1	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
ECOG Performance Status 2	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Continuous Patient Reported Mouth-Pain Score	0 scores on a scale STANDARD_DEVIATION 0 • n=5 Participants	0.1 scores on a scale STANDARD_DEVIATION 0.24 • n=7 Participants	0.03 scores on a scale STANDARD_DEVIATION 0.17 • n=5 Participants
Discrete Patient Reported Mouth-Pain Score = 0	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Discrete Patient Reported Mouth-Pain Score > 0	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.

Outcome measures

Measure	Group I (Dexamethasone) n=16 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks. Dexamethasone: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care	Group II (Placebo) n=17 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks. Placebo: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale No Pain	7 Participants	8 Participants
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale Pain	9 Participants	9 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.

Outcome measures

Measure	Group I (Dexamethasone) n=16 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks. Dexamethasone: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care	Group II (Placebo) n=17 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks. Placebo: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care
Severity of Mouth Pain Scores	11.3 scores on scale * days Standard Deviation 14.83	4.6 scores on scale * days Standard Deviation 6.86

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

Grade 2 mIAS is defined as having at least one of the following criteria:>

1. Oral intake assessed at 50 on the Normalcy of Diet Scale

2. Patient's reported oral pain (using visual analogue scale 0-10) that meets one of the following: rating of 7 on two consecutive days rating of 8, 9, or 10 on any one day. The incidence of grade 2 mIAS for each treatment arm will be compared by a Chi-square test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

Will determine if the initiation of dexamethasone at the start of everolimus is associated with the incidence and of mild (score of 1-3), moderate (score of 4-6) and severe (score of 7-10) mouth pain as measured by the NAMPS. Will be assessed by Chi-square tests.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

Will determine if the initiation of dexamethasone at the start of everolimus is associated with the time to development of mild (score of 1-3), moderate (score of 4-6) and severe (score of 7-10) mouth pain as measured by the NAMPS. Will be assessed by Kaplan-Meier and cumulative incidence curves.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

Will determine if the initiation of dexamethasone at the start of everolimus is associated with quality of life is by comparing numerical analogue scale scores as measured by the Linear Analogue Self-Assessment. The Linear Analogue Self Assessment for quality of life is measured on a 0 to 10 scale, with 0 corresponding to "Quality of life as bad as it can be" and 10 corresponding to "Quality of life as good as it can be." Will be assessed by independent samples t-tests.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

Will determine if the initiation of dexamethasone at the start of everolimus is associated with the level of interference with daily activities as measured by the Patient Reported Outcome (PRO) Common Terminology criteria for Adverse Events (CTCAE) mouth/throat item regarding level of interference with daily activities. The PRO-CTCAE mouth/throat item regarding level of interference with daily activities is measured on a Likert 1-5 scale, with 1 corresponding to "Not at all" and 5 corresponding to "Very much." Will be assessed by independent samples t-tests.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

Will determine if the initiation of dexamethasone at the start of everolimus is associated with the level of interference with daily activities as measured by the PRO-CTCAE sleep item regarding level of interference with daily activities. The PRO-CTCAE sleep item regarding level of interference with daily activities is measured on a Likert 1-5 scale, with 1 corresponding to "Not at all" and 5 corresponding to "Very much." Will be assessed by independent samples t-tests.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

Will compare mean daily dose of everolimus between the arms. The mean daily dose of everolimus over 8 weeks will be compared between study arms using independent samples t-tests.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

Will compare the number of patients who stopped everolimus early between the treatment arms. Will be compared using Chi-squared tests.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

Will compare the number of patients who reduced their everolimus dose between the treatment arms. Will be compared using Chi-squared tests.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

Will compare dexamethasone prescription fill rates between the treatment groups. This will be compared using Chi-squared tests.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

Will compare the time to dexamethasone prescription fill between the treatment groups. This will be compared using Kaplan-Meier and cumulative incidence curves.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

The time to develop at least mild, moderate, or severe (including "Very severe") mouth sores per study arm as measured by the PRO-CTCAE mouth-throat sore item regarding severity. The PRO-CTCAE mouth-throat sore item regarding severity is measured on a Likert 1-5 scale, with 1 corresponding to "None" and 5 corresponding to "Very severe". Will be assessed by Kaplan-Meier and cumulative incidence curves.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

The mean degrees of patient-reported mouth sores per study arm as measured by the NAMPS will be assessed by independent samples t-tests.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

The median degrees of patient-reported mouth sores per study arm as measured by the NAMPS will be assessed by independent samples t-tests.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 months

Population: Original plan for collecting and analyzing this data did not occur due to study termination.

Original plan for collecting and analyzing this data did not occur due to study termination.

The proportion of patients who experience clinician-reported grade 2 stomatitis (as measured by the CTCAE and performed at 1 and 2 months post-baseline) per study arm will be assessed by Chi-squared tests.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 8 weeks

Population: Population is by Sex. Male and Female population combined equals Overall Number of Participants Analyzed.

NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.

Outcome measures

Measure	Group I (Dexamethasone) n=16 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks. Dexamethasone: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care	Group II (Placebo) n=17 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks. Placebo: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Sex Female · No Pain	5 Participants	8 Participants
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Sex Female · Pain	7 Participants	7 Participants
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Sex Male · No Pain	2 Participants	0 Participants
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Sex Male · Pain	2 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 8 weeks

Population: Black or African American population is different than white population

NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.

Outcome measures

Measure	Group I (Dexamethasone) n=16 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks. Dexamethasone: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care	Group II (Placebo) n=17 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks. Placebo: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Race Black or African American · No Pain	1 Participants	0 Participants
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Race Black or African American · Pain	3 Participants	1 Participants
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Race White · No Pain	6 Participants	8 Participants
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Race White · Pain	6 Participants	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 8 weeks

Population: Population is by Ethnicity. Not Hispanic or Latino and Other population combined equals Overall Number of Participants Analyzed.

NIH-required analysis. The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.

Outcome measures

Measure	Group I (Dexamethasone) n=16 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks. Dexamethasone: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care	Group II (Placebo) n=17 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks. Placebo: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Ethnicity. Not Hispanic or Latino · No Pain	6 Participants	7 Participants
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Ethnicity. Not Hispanic or Latino · Pain	9 Participants	9 Participants
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Ethnicity. Other · No Pain	1 Participants	1 Participants
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Ethnicity. Other · Pain	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 8 weeks

Population: Population is by Sex. Male and Female population combined equals Overall Number of Participants Analyzed.

Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.

Outcome measures

Measure	Group I (Dexamethasone) n=16 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks. Dexamethasone: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care	Group II (Placebo) n=17 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks. Placebo: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care
Severity of Mouth Pain Scores by Sex Female	11.4 scores on scale * days Interval 0.0 to 47.3	2.7 scores on scale * days Interval 0.0 to 15.7
Severity of Mouth Pain Scores by Sex Male	11.0 scores on scale * days Interval 0.0 to 33.4	18.8 scores on scale * days Interval 17.0 to 20.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 8 weeks

Population: Population is by Race. Black or African American and White population combined equals Overall Number of Participants Analyzed.

Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.

Outcome measures

Measure	Group I (Dexamethasone) n=16 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks. Dexamethasone: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care	Group II (Placebo) n=17 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks. Placebo: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care
Severity of Mouth Pain Scores by Race Black or African American	9.3 scores on scale * days Interval 0.0 to 22.8	7.9 scores on scale * days Interval 7.9 to 7.9
Severity of Mouth Pain Scores by Race White	12.0 scores on scale * days Interval 0.0 to 47.3	4.4 scores on scale * days Interval 0.0 to 20.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 8 weeks

Population: Population is by Ethnicity. Not Hispanic or Latino and Other population combined equals Overall Number of Participants Analyzed.

Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.

Outcome measures

Measure	Group I (Dexamethasone) n=16 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks. Dexamethasone: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care	Group II (Placebo) n=17 Participants Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks. Placebo: Given as mouthwash Questionnaire: Ancillary studies Quality-of-Life Assessment: Ancillary studies Everolimus: Standard of care
Severity of Mouth Pain Scores by Ethnicity Not Hispanic or Latino	12.1 scores on scale * days Interval 0.0 to 47.3	4.9 scores on scale * days Interval 0.0 to 20.7
Severity of Mouth Pain Scores by Ethnicity Other	0.0 scores on scale * days Interval 0.0 to 0.0	0.0 scores on scale * days Interval 0.0 to 0.0

Adverse Events

Group II (Placebo)

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Group I (Dexamethasone)

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group II (Placebo) n=18 participants at risk Everolimus: Standard of care	Group I (Dexamethasone) n=17 participants at risk Everolimus: Standard of care
Cardiac disorders Sinus tachycardia	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
General disorders Edema limbs	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Infections and infestations Enterocolitis infectious	0.00% 0/18 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	5.9% 1/17 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Investigations Creatinine increased	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Metabolism and nutrition disorders Dehydration	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Metabolism and nutrition disorders Hyponatremia	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/18 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	5.9% 1/17 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/18 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	5.9% 1/17 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.

Other adverse events

Measure	Group II (Placebo) n=18 participants at risk Everolimus: Standard of care	Group I (Dexamethasone) n=17 participants at risk Everolimus: Standard of care
Blood and lymphatic system disorders Anemia	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	5.9% 1/17 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Blood and lymphatic system disorders Blood and lymph sys disorders - Oth Spec	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Gastrointestinal disorders Colitis	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Gastrointestinal disorders Diarrhea	11.1% 2/18 • Number of events 2 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Gastrointestinal disorders Dry mouth	11.1% 2/18 • Number of events 5 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Gastrointestinal disorders Gastrointestinal disorders - Oth spec	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Gastrointestinal disorders Mucositis oral	33.3% 6/18 • Number of events 15 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	41.2% 7/17 • Number of events 29 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Gastrointestinal disorders Nausea	16.7% 3/18 • Number of events 6 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	11.8% 2/17 • Number of events 2 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Gastrointestinal disorders Oral pain	33.3% 6/18 • Number of events 16 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	41.2% 7/17 • Number of events 29 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Gastrointestinal disorders Vomiting	0.00% 0/18 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	5.9% 1/17 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
General disorders Fatigue	77.8% 14/18 • Number of events 57 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	52.9% 9/17 • Number of events 36 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Infections and infestations Mucosal infection	0.00% 0/18 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	11.8% 2/17 • Number of events 2 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Injury, poisoning and procedural complications Bruising	5.6% 1/18 • Number of events 3 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	5.9% 1/17 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Injury, poisoning and procedural complications Fracture	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Investigations Alanine aminotransferase increased	11.1% 2/18 • Number of events 4 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Investigations Alkaline phosphatase increased	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	5.9% 1/17 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Investigations Aspartate aminotransferase increased	11.1% 2/18 • Number of events 3 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Investigations Creatinine increased	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Investigations Platelet count decreased	5.6% 1/18 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	5.9% 1/17 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Investigations White blood cell decreased	0.00% 0/18 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	5.9% 1/17 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Metabolism and nutrition disorders Anorexia	16.7% 3/18 • Number of events 3 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Metabolism and nutrition disorders Hyperglycemia	33.3% 6/18 • Number of events 14 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	35.3% 6/17 • Number of events 15 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 1/18 • Number of events 4 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Musculoskeletal and connective tissue disorders Back pain	5.6% 1/18 • Number of events 3 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/18 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	5.9% 1/17 • Number of events 2 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/18 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	5.9% 1/17 • Number of events 2 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Nervous system disorders Dysgeusia	11.1% 2/18 • Number of events 5 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/18 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	5.9% 1/17 • Number of events 1 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Psychiatric disorders Depression	5.6% 1/18 • Number of events 3 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Psychiatric disorders Insomnia	50.0% 9/18 • Number of events 40 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	23.5% 4/17 • Number of events 20 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Psychiatric disorders Irritability	16.7% 3/18 • Number of events 10 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	11.8% 2/17 • Number of events 4 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Reproductive system and breast disorders Breast pain	5.6% 1/18 • Number of events 3 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	0.00% 0/17 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/18 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	5.9% 1/17 • Number of events 2 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.
Skin and subcutaneous tissue disorders Rash acneiform	5.6% 1/18 • Number of events 4 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.	5.9% 1/17 • Number of events 2 • 8 weeks 3 patients in Dexamethasone Arm withdrew prior to starting treatment and no AE data was collected. Out of 20 randomized patients in Dexamethasone arm, 17 patients had AE data. 1 patient in Placebo Arm had a protocol violation. Patient did no start Everolimus and no AE data was collected. Out of 19 randomized patients in Placebo arm, 18 patients had AE data.

Additional Information

Dr. Kathryn J. Ruddy

Mayo Clinic

Phone: 507-293-1732

Email: ruddy.kathryn@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place