Trial Outcomes & Findings for Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation (NCT NCT01856543)

Last Updated: 2019-10-03

Results Overview

Skin toxicity assessments will be done on a weekly basis while the patient is receiving RT, by the RN or physician utilizing CTCAE 4.0 and the weekly status check form, as per current standard practice.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

143 participants

Primary outcome timeframe

2 years

Results posted on

2019-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Eucerin Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT. Eucerin	Mometasone Furoate 0.1% Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Mometasone F
Overall Study STARTED	73	70
Overall Study COMPLETED	60	64
Overall Study NOT COMPLETED	13	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Eucerin Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT. Eucerin	Mometasone Furoate 0.1% Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Mometasone F
Overall Study Treatment discontinued	6	3
Overall Study Withdrawn before start	7	3

Baseline Characteristics

Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eucerin n=73 Participants Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT. Eucerin	Mometasone Furoate 0.1% n=70 Participants Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Mometasone F	Total n=143 Participants Total of all reporting groups
Age, Continuous	49 years n=5 Participants	48 years n=7 Participants	49 years n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants	70 Participants n=7 Participants	143 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	6 Participants n=5 Participants	7 Participants n=7 Participants	13 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	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	46 Participants n=7 Participants	95 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	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	73 Participants n=5 Participants	70 Participants n=7 Participants	143 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Eucerin n=73 Participants Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT. Eucerin	Mometasone Furoate 0.1% n=70 Participants Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Mometasone F
Percentage of Participants With Moist Desquamation	66.7 % of participants w/moist desquamation	43.8 % of participants w/moist desquamation

SECONDARY outcome

Timeframe: 5 weeks and Baseline

The Skindex-16 assessment tool is designed to capture patient-reported assessments of subjective adverse effects. It consists of a short 16-item assessment completed by the patient, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Responses to the Skindex-16 are categorized into three subscales: symptom, emotional, and functional. Scores for the emotions, symptoms and functioning scales are also expressed in a linear scale from 0 to 100. Rankings of the questionnaire are then averaged to obtain a score of severity of patient-reported outcomes. This allows providers to gauge which aspects of the participant's experience are most affected by the treatment.

Outcome measures

Outcome measures
Measure	Eucerin n=60 Participants Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT. Eucerin	Mometasone Furoate 0.1% n=64 Participants Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Mometasone F
Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment Emotions	8.0 score on a scale Standard Deviation 11.4	5.0 score on a scale Standard Deviation 9.1
Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment Symptoms	6.0 score on a scale Standard Deviation 7.2	6.0 score on a scale Standard Deviation 6.4
Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment Functioning	2.0 score on a scale Standard Deviation 7.4	1.0 score on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: 2 weeks after end of Radiation Therapy

Outcome measures

Outcome measures
Measure	Eucerin n=60 Participants Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT. Eucerin	Mometasone Furoate 0.1% n=64 Participants Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Mometasone F
Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up Emotions	15.0 scores on a scale Standard Deviation 12.3	12.0 scores on a scale Standard Deviation 12.8
Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up Symptoms	11.0 scores on a scale Standard Deviation 7.4	11.0 scores on a scale Standard Deviation 6.7
Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up Functioning	6.0 scores on a scale Standard Deviation 7.9	5.0 scores on a scale Standard Deviation 9.1

Adverse Events

Eucerin

Serious events: 3 serious events

Other events: 25 other events

Deaths: 5 deaths

Mometasone Furoate 0.1%

Serious events: 3 serious events

Other events: 29 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Eucerin n=73 participants at risk Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT. Eucerin	Mometasone Furoate 0.1% n=70 participants at risk Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Mometasone F
Cardiac disorders Chest Pain - cardiac	1.4% 1/73 • Up to 12 months	0.00% 0/70 • Up to 12 months
Respiratory, thoracic and mediastinal disorders Dyspnea	1.4% 1/73 • Up to 12 months	0.00% 0/70 • Up to 12 months
Cardiac disorders Myocarditis	1.4% 1/73 • Up to 12 months	0.00% 0/70 • Up to 12 months
Cardiac disorders Pericarditis	1.4% 1/73 • Up to 12 months	0.00% 0/70 • Up to 12 months
Cardiac disorders Ventricular tachycardia	1.4% 1/73 • Up to 12 months	0.00% 0/70 • Up to 12 months
Injury, poisoning and procedural complications Dermatitis radiation	0.00% 0/73 • Up to 12 months	1.4% 1/70 • Up to 12 months
Infections and infestations Skin infection	0.00% 0/73 • Up to 12 months	2.9% 2/70 • Up to 12 months

Other adverse events

Other adverse events
Measure	Eucerin n=73 participants at risk Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT. Eucerin	Mometasone Furoate 0.1% n=70 participants at risk Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Mometasone F
Investigations Lymphocyte count decreased	17.8% 13/73 • Up to 12 months	14.3% 10/70 • Up to 12 months
Investigations White blood cell decreased	8.2% 6/73 • Up to 12 months	11.4% 8/70 • Up to 12 months
Injury, poisoning and procedural complications Dermatitis radiation	5.5% 4/73 • Up to 12 months	1.4% 1/70 • Up to 12 months
Investigations Neutrophil count decreased	1.4% 1/73 • Up to 12 months	4.3% 3/70 • Up to 12 months
Metabolism and nutrition disorders Hyperglycemia	1.4% 1/73 • Up to 12 months	1.4% 1/70 • Up to 12 months
Blood and lymphatic system disorders Anemia	0.00% 0/73 • Up to 12 months	4.3% 3/70 • Up to 12 months
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/73 • Up to 12 months	1.4% 1/70 • Up to 12 months
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/73 • Up to 12 months	1.4% 1/70 • Up to 12 months
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/73 • Up to 12 months	1.4% 1/70 • Up to 12 months

Additional Information

Dr. Daphna Gelblum

Memorial Sloan Kettering Cancer Center

Phone: 914-367-7273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place