Trial Outcomes & Findings for Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis (NCT NCT01952847)

Results Overview

For esophagus radiation participants, the severity of esophagitis will be taken as the highest grade observed by week six. Wilcoxon rank sum test used to compare the ordered categories of esophagitis severity.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

77 participants

Primary outcome timeframe

6 weeks

Results posted on

2022-06-15

Participant Flow

The mTOR inhibitor cohort 24 patients consented. 10 enrolled patients became ineligible after consent and before randomization due to changes in their treatment plan. The radiation cohort enrolled 53 patients; 27 were randomized to the glutamine arm and 26 were randomized to the placebo arm.

Participant milestones

Participant milestones
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	mTOR Inhibitor Patient Group - Glutamine Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit.	mTOR Inhibitor Patient Group - Placebo Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit.
Overall Study STARTED	27	26	7	7
Overall Study COMPLETED	25	24	7	6
Overall Study NOT COMPLETED	2	2	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	mTOR Inhibitor Patient Group - Placebo Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit.
Overall Study Ineligible	1	0	0
Overall Study Lack of Insurance Coverage	0	1	0
Overall Study Withdrawal by Subject	1	1	1

Baseline Characteristics

no data for BMI taken for the mTOR cohort

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=27 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=26 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	mTOR Inhibitor Patient Group - Glutamine n=7 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit.	mTOR Inhibitor Patient Group - Placebo n=6 Participants Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit.	Total n=66 Participants Total of all reporting groups
Age, Continuous	67.6 years STANDARD_DEVIATION 9.8 • n=27 Participants	64.9 years STANDARD_DEVIATION 11.8 • n=26 Participants	64.3 years STANDARD_DEVIATION 10.5 • n=7 Participants	60.3 years STANDARD_DEVIATION 13.4 • n=6 Participants	65.8 years STANDARD_DEVIATION 11.0 • n=66 Participants
Sex: Female, Male Female	13 Participants n=27 Participants	9 Participants n=26 Participants	7 Participants n=7 Participants	6 Participants n=6 Participants	35 Participants n=66 Participants
Sex: Female, Male Male	14 Participants n=27 Participants	17 Participants n=26 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	31 Participants n=66 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=27 Participants	0 Participants n=26 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=66 Participants
Race (NIH/OMB) Asian	0 Participants n=27 Participants	0 Participants n=26 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=66 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=27 Participants	0 Participants n=26 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=66 Participants
Race (NIH/OMB) Black or African American	1 Participants n=27 Participants	6 Participants n=26 Participants	2 Participants n=7 Participants	1 Participants n=6 Participants	10 Participants n=66 Participants
Race (NIH/OMB) White	26 Participants n=27 Participants	20 Participants n=26 Participants	5 Participants n=7 Participants	5 Participants n=6 Participants	56 Participants n=66 Participants
Race (NIH/OMB) More than one race	0 Participants n=27 Participants	0 Participants n=26 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=66 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=27 Participants	0 Participants n=26 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=66 Participants
Region of Enrollment United States	27 participants n=27 Participants	26 participants n=26 Participants	7 participants n=7 Participants	6 participants n=6 Participants	66 participants n=66 Participants
Cancer Type Esophageal	2 Participants n=27 Participants	4 Participants n=26 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	6 Participants n=66 Participants
Cancer Type Head & Neck	1 Participants n=27 Participants	0 Participants n=26 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	1 Participants n=66 Participants
Cancer Type Lung	23 Participants n=27 Participants	22 Participants n=26 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	45 Participants n=66 Participants
Cancer Type Sarcoma	1 Participants n=27 Participants	0 Participants n=26 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	1 Participants n=66 Participants
Cancer Type Endometrial cancer	0 Participants n=27 Participants	0 Participants n=26 Participants	7 Participants n=7 Participants	6 Participants n=6 Participants	13 Participants n=66 Participants
BMI	27.0 kg/m^2 STANDARD_DEVIATION 5.1 • n=27 Participants • no data for BMI taken for the mTOR cohort	28.2 kg/m^2 STANDARD_DEVIATION 4.7 • n=26 Participants • no data for BMI taken for the mTOR cohort	—	—	27.6 kg/m^2 STANDARD_DEVIATION 4.9 • n=53 Participants • no data for BMI taken for the mTOR cohort

PRIMARY outcome

Timeframe: 6 weeks

Population: Participants who took at least 60% of the planned doses of the study treatment and were evaluable per protocol definition.

For esophagus radiation participants, the severity of esophagitis will be taken as the highest grade observed by week six. Wilcoxon rank sum test used to compare the ordered categories of esophagitis severity.

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=19 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=19 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Severity of Esophagitis for Radiation Therapy Patients Grade 1	2 Participants	0 Participants
Severity of Esophagitis for Radiation Therapy Patients Grade 2	5 Participants	8 Participants
Severity of Esophagitis for Radiation Therapy Patients Grade 3	7 Participants	5 Participants
Severity of Esophagitis for Radiation Therapy Patients Absent	5 Participants	6 Participants

PRIMARY outcome

Timeframe: 6 months after start of mTOR inhibitor based treatment

Population: Evaluable Participants in the mTOR Inhibitor Cohort

For mTOR inhibitor patients, the severity of oral mucositis will be taken as the maximum grade observed during the 6-month study period. Wilcoxon rank sum test used to compare the ordered categories of mucositis severity.

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=7 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=6 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Severity of Oral Mucositis for mTOR Inhibitor Patients Grade 1	1 Participants	3 Participants
Severity of Oral Mucositis for mTOR Inhibitor Patients Grade 2	0 Participants	0 Participants
Severity of Oral Mucositis for mTOR Inhibitor Patients Grade 3	1 Participants	0 Participants
Severity of Oral Mucositis for mTOR Inhibitor Patients Absent	5 Participants	3 Participants

SECONDARY outcome

Timeframe: at baseline

The Quality of Life assessed by the MD Anderson Symptom Inventory for head and neck cancer (MDASI-HN). The 13 Core symptoms include dry mouth, fatigue, pain, disturbed sleep, drowsiness, feeling of being distressed, anorexia, sadness, numbness/tingling, dyspnea, difficulty remembering, nausea, and vomiting. The 9 Head and Neck symptoms include mouth sores, problems with taste, constipation, teeth/gum problems, skin pain, difficulty with voice, choking/coughing, difficulty swallowing, and problems with mucus specific to head and neck cancers. Total symptom severity include 24 core and Head and Neck symptoms together. Symptom interference asks patients about how their symptoms impact their daily functions. The severity of each symptom and symptom interference is rated on a numerical scale from 0 (symptom is absent) to 10 (worst possible severity)." Higher scores indicate a greater symptom burden.

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=27 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=26 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Quality of Life (QOL) in Esophagus Radiation Patients at Baseline Total Symptom Severity	1.0 score on a scale Interval 0.1 to 4.0	1.0 score on a scale Interval 0.0 to 3.4
Quality of Life (QOL) in Esophagus Radiation Patients at Baseline Core Symptom Severity	1.4 score on a scale Interval 0.2 to 5.3	1.3 score on a scale Interval 0.0 to 4.3
Quality of Life (QOL) in Esophagus Radiation Patients at Baseline Head & Neck symptom Severity	0.4 score on a scale Interval 0.0 to 2.3	0.6 score on a scale Interval 0.0 to 3.4
Quality of Life (QOL) in Esophagus Radiation Patients at Baseline Symptom Interference Severity	0.5 score on a scale Interval 0.0 to 7.0	0.5 score on a scale Interval 0.0 to 7.2

SECONDARY outcome

Timeframe: at baseline

The Quality of Life assessed by the MD Anderson Symptom Inventory for head and neck cancer (MDASI-HN). The 13 Core symptoms include dry mouth, fatigue, pain, disturbed sleep, drowsiness, feeling of being distressed, anorexia, sadness, numbness/tingling, dyspnea, difficulty remembering, nausea, and vomiting. The 9 Head and Neck symptoms include mouth sores, problems with taste, constipation, teeth/gum problems, skin pain, difficulty with voice, choking/coughing, difficulty swallowing, and problems with mucus specific to head and neck cancers. Total symptom severity include 24 core and Head and Neck symptoms together. Symptom interference asks patients about how their symptoms impact their daily functions. The severity of each symptom and symptom interference is rated on a numerical scale from 0 (symptom is absent) to 10 (worst possible severity)." Higher scores indicate a greater symptom burden.

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=7 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=6 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Quality of Life (QOL) in mTOR Inhibitor Patients at Baseline Total Symptom severity	1.0 score on a scale Interval 0.1 to 3.4	1.0 score on a scale Interval 0.1 to 3.9
Quality of Life (QOL) in mTOR Inhibitor Patients at Baseline Core Symptom severity	1.3 score on a scale Interval 0.2 to 4.3	1.5 score on a scale Interval 0.2 to 5.0
Quality of Life (QOL) in mTOR Inhibitor Patients at Baseline Head & Neck symptom severity	0.4 score on a scale Interval 0.0 to 2.6	0.3 score on a scale Interval 0.0 to 2.3
Quality of Life (QOL) in mTOR Inhibitor Patients at Baseline Symptom Interference severity	0.3 score on a scale Interval 0.0 to 6.5	0.9 score on a scale Interval 0.0 to 7.7

SECONDARY outcome

Timeframe: 6 weeks

Population: Evaluable participant

Participants in each arm received at least 60% of planned doses of the study drug (glutamine or placebo).

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=19 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=19 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Number of Participants With Esophagitis During 6 Weeks After Radiation Treatment Start None	5 Participants	6 Participants
Number of Participants With Esophagitis During 6 Weeks After Radiation Treatment Start Esophagitis	14 Participants	13 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=7 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=6 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Mucositis Incidence Per Participant During 6 Months After mTOR Inhibitor Treatment Start None	5 Participants	3 Participants
Mucositis Incidence Per Participant During 6 Months After mTOR Inhibitor Treatment Start Mucositis	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=19 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=19 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Grade 3 or Higher Esophagitis Incidence Per Participant During 6 Weeks After Radiation Start Absent, Grade 1 or 2	12 Participants	14 Participants
Grade 3 or Higher Esophagitis Incidence Per Participant During 6 Weeks After Radiation Start Grade 3	7 Participants	5 Participants

SECONDARY outcome

Timeframe: 6 month

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=7 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=6 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Grade 3 or Higher Mucositis Incidence Per Participant During 6 Months After Treatment Start Grade 3	1 Participants	0 Participants
Grade 3 or Higher Mucositis Incidence Per Participant During 6 Months After Treatment Start Absent, Grade 1 or 2	6 Participants	6 Participants

SECONDARY outcome

Timeframe: From event starts to end of study visit

Population: Participants in the radiation cohort who experienced esophagitis.

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=14 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=13 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Duration of Esophagitis After Radiation Treatment Start	6.3 weeks Interval 1.0 to 32.4	7.1 weeks Interval 2.6 to 44.0

SECONDARY outcome

Timeframe: From event starts to end of study visit

Population: Participants in the mTOR cohort who experienced mucositis.

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=2 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=3 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Duration of Mucositis After mTOR Inhibitor Treatment Start	10.9 weeks Interval 6.1 to 15.7	9.0 weeks Interval 4.6 to 23.1

SECONDARY outcome

Timeframe: From radiation starts to end of study visit

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=19 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=19 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Time to Esophagitis on the Radiation Cohort Onset	2.9 weeks Interval 2.4 to 4.1	4.1 weeks Interval 3.1 to 5.9

SECONDARY outcome

Timeframe: 18.3 weeks

Proportion of participants who were free of Mucositis at 18.3 weeks..

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=7 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=6 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Proportion of Participants Who Were Mucositis-Free at 18.3 Weeks	71 percentage of participants Interval 26.0 to 92.0	33 percentage of participants Interval 1.0 to 75.0

SECONDARY outcome

Timeframe: From radiation treatment start to end of study visit, approximately 6 months

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=19 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=19 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Number of Participants With Cancer Treatment Interruptions Due to Esophagitis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months after start of mTOR inhibitor based treatment

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=7 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=6 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Number of Participants With Cancer Treatment Interruptions Due to Mucositis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from baseline to 6 months post radiation therapy

Investigators recorded weight at baseline to the end of treatment with glutamine/placebo. Weight loss calculated at each study assessment visit using the Wilcoxon rank sum test.

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=19 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=19 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Radiation Cohort Participant Weight Change From Baseline to End of Study	-0.9 kg Interval -8.7 to 4.2	-2.8 kg Interval -9.2 to 3.6

SECONDARY outcome

Timeframe: baseline, weekly during Cycle 1, and Day 1 of Cycle 2 and beyond, and 4 weeks and 6 months after the last dose of the mTOR inhibitor

Investigators recorded the weight at baseline and the end of the study. Weight loss calculated at each study assessment visit using the Wilcoxon rank sum test.

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=7 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=6 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
mTOR Inhibitor Cohort Participant Weight Change From Baseline to End of Study	-5.4 kg Interval -13.9 to 0.5	-4.3 kg Interval -13.2 to -0.2

SECONDARY outcome

Timeframe: weekly during radiation, 1 month and 6 months post radiation therapy until resolution, stabilization, death, loss to follow up, or commencement of new therapy

Population: Total toxicity-evaluable is the total number of participants who had at least one dose of glutamine or placebo.

CTCAE version 4.03 used to access the adverse events. Grade 1 Asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2 Symptomatic; altered eating/swallowing; oral supplements indicated Grade 3 Severely altered eating/swallowing; tube feeding, TPN or hospitalization indicated. Total toxicity-evaluable is the total number of participants who had at least one dose of glutamine or placebo.

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=25 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=24 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Summary of Adverse Events by Grade and Relationship - Radiation Cohort Grade 3 Unlikely Related	1 adverse events	0 adverse events
Summary of Adverse Events by Grade and Relationship - Radiation Cohort Grade 3 Unrelated	13 adverse events	11 adverse events
Summary of Adverse Events by Grade and Relationship - Radiation Cohort Grade 2 Possibly related	2 adverse events	1 adverse events
Summary of Adverse Events by Grade and Relationship - Radiation Cohort Grade 2 Unlikely related	0 adverse events	0 adverse events
Summary of Adverse Events by Grade and Relationship - Radiation Cohort Grade 2 Unrelated	15 adverse events	15 adverse events
Summary of Adverse Events by Grade and Relationship - Radiation Cohort Grade 1 Possibly related	3 adverse events	0 adverse events
Summary of Adverse Events by Grade and Relationship - Radiation Cohort Grade 1 Unlikely related	1 adverse events	0 adverse events
Summary of Adverse Events by Grade and Relationship - Radiation Cohort Grade 1 Unrelated	7 adverse events	0 adverse events

SECONDARY outcome

Timeframe: weekly during Cycle 1, and Day 1 of Cycle 2 and beyond, and 4 weeks and 6 months after the last dose of the mTOR inhibitor until resolution, stabilization, death, loss to follow up, or commencement of new therapy

CTCAE version 4.03 used to access the adverse events. Grade 1 Asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2 Symptomatic; altered eating/swallowing; oral supplements indicated Grade 3 Severely altered eating/swallowing; tube feeding, TPN or hospitalization indicated. Total toxicity-evaluable is the total number of participants who had at least one dose of glutamine or placebo

Outcome measures

Outcome measures
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=7 Participants Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=6 Participants Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.
Summary of Adverse Events by Grade and Relationship - mTOR Inhibitor Cohort Grade 3 Unrelated	3 adverse events	3 adverse events
Summary of Adverse Events by Grade and Relationship - mTOR Inhibitor Cohort Grade 2 Unrelated	0 adverse events	2 adverse events
Summary of Adverse Events by Grade and Relationship - mTOR Inhibitor Cohort Grade 1 Unrelated	6 adverse events	6 adverse events

Adverse Events

Radiation Therapy to Esophagus Patient Group - Glutamine

Serious events: 5 serious events

Other events: 20 other events

Deaths: 6 deaths

Radiation Therapy to Esophagus Patient Group - Placebo

Serious events: 3 serious events

Other events: 15 other events

Deaths: 2 deaths

mTOR Inhibitor Patient Group - Glutamine

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

mTOR Inhibitor Patient Group - Placebo

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Radiation Therapy to Esophagus Patient Group - Glutamine n=25 participants at risk Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	Radiation Therapy to Esophagus Patient Group - Placebo n=24 participants at risk Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit.	mTOR Inhibitor Patient Group - Glutamine n=7 participants at risk Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit.	mTOR Inhibitor Patient Group - Placebo n=6 participants at risk Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit.
Gastrointestinal disorders Esophagitis	8.0% 2/25 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	8.3% 2/24 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/7 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/6 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/25 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	4.2% 1/24 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/7 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/6 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.
Cardiac disorders Heart failure	4.0% 1/25 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/24 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/7 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/6 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.
Vascular disorders Hypotension	0.00% 0/25 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	4.2% 1/24 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/7 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/6 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.
Infections and infestations Lung infection	4.0% 1/25 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	4.2% 1/24 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/7 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/6 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.
Gastrointestinal disorders Nausea	0.00% 0/25 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/24 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	14.3% 1/7 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/6 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.
Respiratory, thoracic and mediastinal disorders Pulmonary hypretension	4.0% 1/25 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/24 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/7 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/6 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorder	4.0% 1/25 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/24 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/7 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/6 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/25 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/24 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/7 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	16.7% 1/6 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.
Gastrointestinal disorders Vomiting	0.00% 0/25 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/24 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	14.3% 1/7 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/6 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.
Metabolism and nutrition disorders Dehydration	0.00% 0/25 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	4.2% 1/24 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/7 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/6 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.
Gastrointestinal disorders Diarrhea	0.00% 0/25 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	0.00% 0/24 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	14.3% 1/7 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.	16.7% 1/6 • From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.

Other adverse events

Additional Information

Aung Naing, MD-Professor, Invest. Cancer Therapeutics

UT MD Anderson Cancer Center

Phone: (713) 563-3885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place