Trial Outcomes & Findings for Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy (NCT NCT04989504)
NCT ID: NCT04989504
Last Updated: 2025-04-29
Results Overview
Scores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a patient-completed mRISRAS score ranges from 0 to 12, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
216 participants
Primary outcome timeframe
Up to 5 months
Results posted on
2025-04-29
Participant Flow
Participant milestones
| Measure |
Arm I (Standard of Care)
Patients receive standard of care skin management during radiation therapy for up to 6 weeks.\>
\> Best Practice: Receive standard of care\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Mepitel Film)
Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.\>
\> Wound Dressing Material: Apply Mepitel Film\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
143
|
|
Overall Study
COMPLETED
|
65
|
143
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy
Baseline characteristics by cohort
| Measure |
Arm I (Standard of Care)
n=73 Participants
Patients receive standard of care skin management during radiation therapy for up to 6 weeks.\>
\> Best Practice: Receive standard of care\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Mepitel Film)
n=143 Participants
Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.\>
\> Wound Dressing Material: Apply Mepitel Film\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
53 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ever Received Boost
Yes
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ever Received Boost
No
|
53 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 monthsScores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a patient-completed mRISRAS score ranges from 0 to 12, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.
Outcome measures
| Measure |
Arm I (Standard of Care)
n=60 Participants
Patients receive standard of care skin management during radiation therapy for up to 6 weeks.
\>
\> Best Practice: Receive standard of care
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Mepitel Film)
n=132 Participants
Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.
\>
\> Wound Dressing Material: Apply Mepitel Film
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
|
46.24 score on a scale*month
Interval 38.42 to 54.06
|
35.32 score on a scale*month
Interval 29.4 to 41.23
|
SECONDARY outcome
Timeframe: Up to 2 monthsAt the completion of radiation therapy, photographs will be obtained one hour after the removal of the Mepitel Film or immediately following completion of radiation therapy for patients on the standard of care arm. A panel of radiation oncology providers will perform the blinded, central review to score the photographs. Each provider will independently assign a provider-completed mRISRAS score to each photograph, and the average score will be calculated for each patient. The provider-completed mRISRAS score ranges from 0 to 24, where higher scores correspond to increased radiation-induced skin reactions. The Wilcoxon rank-sum test will be used to test for an effect of the Mepitel Film.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 monthsScores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a provider-completed mRISRAS score ranges from 0 to 24, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.
Outcome measures
| Measure |
Arm I (Standard of Care)
n=60 Participants
Patients receive standard of care skin management during radiation therapy for up to 6 weeks.
\>
\> Best Practice: Receive standard of care
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Mepitel Film)
n=132 Participants
Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.
\>
\> Wound Dressing Material: Apply Mepitel Film
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Serially Measured Non-blinded Institutional Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
|
8.0 score on a scale*month
Interval 7.0 to 9.0
|
8.0 score on a scale*month
Interval 3.0 to 9.0
|
SECONDARY outcome
Timeframe: Up to 5 monthsScores obtained at baseline (i.e. prior to the start of radiation), during weekly radiation therapy, at 10 (±4) days post-radiation therapy, and at 3-months post radiation therapy. At a given measurement time point, a provider-completed mRISRAS score ranges from 0 to 36, where higher scores correspond to increased radiation-induced skin reactions. The effect of the Mepitel Film in reducing the severity of radiation dermatitis will be defined as the between-arm difference in the summary statistic area under the curve obtained from a repeated-measures (means) mixed model.
Outcome measures
| Measure |
Arm I (Standard of Care)
n=60 Participants
Patients receive standard of care skin management during radiation therapy for up to 6 weeks.
\>
\> Best Practice: Receive standard of care
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Mepitel Film)
n=132 Participants
Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.
\>
\> Wound Dressing Material: Apply Mepitel Film
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Serially Measured Combined Patient- and Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
|
16.0 score on a scale*month
Interval 14.0 to 18.0
|
16.0 score on a scale*month
Interval 6.0 to 18.0
|
Adverse Events
Arm I (Standard of Care)
Serious events: 2 serious events
Other events: 59 other events
Deaths: 0 deaths
Arm II (Mepitel Film)
Serious events: 7 serious events
Other events: 133 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Standard of Care)
n=65 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm II (Mepitel Film)
n=143 participants at risk
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Infections and infestations
Lung infection
|
0.00%
0/65 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/65 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/65 • Up to 5 months
|
1.4%
2/143 • Number of events 2 • Up to 5 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.5%
1/65 • Number of events 1 • Up to 5 months
|
0.00%
0/143 • Up to 5 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/65 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
1/65 • Number of events 1 • Up to 5 months
|
2.1%
3/143 • Number of events 3 • Up to 5 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/65 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
Other adverse events
| Measure |
Arm I (Standard of Care)
n=65 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm II (Mepitel Film)
n=143 participants at risk
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/65 • Up to 5 months
|
1.4%
2/143 • Number of events 3 • Up to 5 months
|
|
Cardiac disorders
Pericardial effusion
|
1.5%
1/65 • Number of events 1 • Up to 5 months
|
0.00%
0/143 • Up to 5 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/65 • Up to 5 months
|
1.4%
2/143 • Number of events 2 • Up to 5 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/65 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/65 • Number of events 1 • Up to 5 months
|
2.8%
4/143 • Number of events 6 • Up to 5 months
|
|
Gastrointestinal disorders
Esophagitis
|
1.5%
1/65 • Number of events 1 • Up to 5 months
|
5.6%
8/143 • Number of events 20 • Up to 5 months
|
|
Gastrointestinal disorders
Nausea
|
12.3%
8/65 • Number of events 18 • Up to 5 months
|
5.6%
8/143 • Number of events 18 • Up to 5 months
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/65 • Number of events 2 • Up to 5 months
|
0.00%
0/143 • Up to 5 months
|
|
General disorders
Edema limbs
|
1.5%
1/65 • Number of events 1 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
|
General disorders
Fatigue
|
27.7%
18/65 • Number of events 58 • Up to 5 months
|
23.1%
33/143 • Number of events 80 • Up to 5 months
|
|
General disorders
Fever
|
0.00%
0/65 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
|
General disorders
Localized edema
|
4.6%
3/65 • Number of events 10 • Up to 5 months
|
6.3%
9/143 • Number of events 22 • Up to 5 months
|
|
General disorders
Non-cardiac chest pain
|
1.5%
1/65 • Number of events 1 • Up to 5 months
|
0.00%
0/143 • Up to 5 months
|
|
General disorders
Pain
|
3.1%
2/65 • Number of events 2 • Up to 5 months
|
3.5%
5/143 • Number of events 10 • Up to 5 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
1.5%
1/65 • Number of events 1 • Up to 5 months
|
1.4%
2/143 • Number of events 3 • Up to 5 months
|
|
Infections and infestations
Shingles
|
0.00%
0/65 • Up to 5 months
|
0.70%
1/143 • Number of events 2 • Up to 5 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/65 • Up to 5 months
|
5.6%
8/143 • Number of events 14 • Up to 5 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/65 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
86.2%
56/65 • Number of events 211 • Up to 5 months
|
80.4%
115/143 • Number of events 351 • Up to 5 months
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/65 • Up to 5 months
|
1.4%
2/143 • Number of events 10 • Up to 5 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/65 • Up to 5 months
|
0.70%
1/143 • Number of events 5 • Up to 5 months
|
|
Investigations
Lymphocyte count decreased
|
1.5%
1/65 • Number of events 1 • Up to 5 months
|
0.00%
0/143 • Up to 5 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/65 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
|
Investigations
Weight loss
|
1.5%
1/65 • Number of events 2 • Up to 5 months
|
0.00%
0/143 • Up to 5 months
|
|
Investigations
White blood cell decreased
|
1.5%
1/65 • Number of events 4 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
|
Metabolism and nutrition disorders
Anorexia
|
3.1%
2/65 • Number of events 3 • Up to 5 months
|
2.8%
4/143 • Number of events 5 • Up to 5 months
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
1.5%
1/65 • Number of events 6 • Up to 5 months
|
0.00%
0/143 • Up to 5 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/65 • Number of events 4 • Up to 5 months
|
2.8%
4/143 • Number of events 9 • Up to 5 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.5%
1/65 • Number of events 1 • Up to 5 months
|
0.00%
0/143 • Up to 5 months
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
1.5%
1/65 • Number of events 3 • Up to 5 months
|
0.00%
0/143 • Up to 5 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
4.6%
3/65 • Number of events 4 • Up to 5 months
|
0.70%
1/143 • Number of events 2 • Up to 5 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
3.1%
2/65 • Number of events 8 • Up to 5 months
|
0.00%
0/143 • Up to 5 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
2/65 • Number of events 8 • Up to 5 months
|
0.00%
0/143 • Up to 5 months
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
4.6%
3/65 • Number of events 7 • Up to 5 months
|
2.1%
3/143 • Number of events 3 • Up to 5 months
|
|
Nervous system disorders
Headache
|
1.5%
1/65 • Number of events 2 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/65 • Up to 5 months
|
0.70%
1/143 • Number of events 3 • Up to 5 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.6%
3/65 • Number of events 5 • Up to 5 months
|
2.1%
3/143 • Number of events 10 • Up to 5 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/65 • Up to 5 months
|
2.1%
3/143 • Number of events 3 • Up to 5 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/65 • Up to 5 months
|
1.4%
2/143 • Number of events 6 • Up to 5 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.5%
1/65 • Number of events 6 • Up to 5 months
|
0.00%
0/143 • Up to 5 months
|
|
Reproductive system and breast disorders
Breast pain
|
13.8%
9/65 • Number of events 26 • Up to 5 months
|
5.6%
8/143 • Number of events 26 • Up to 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
3/65 • Number of events 4 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.5%
1/65 • Number of events 1 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/65 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.5%
1/65 • Number of events 3 • Up to 5 months
|
0.00%
0/143 • Up to 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.5%
1/65 • Number of events 3 • Up to 5 months
|
0.70%
1/143 • Number of events 1 • Up to 5 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.1%
2/65 • Number of events 12 • Up to 5 months
|
2.1%
3/143 • Number of events 10 • Up to 5 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/65 • Up to 5 months
|
6.3%
9/143 • Number of events 24 • Up to 5 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.5%
1/65 • Number of events 1 • Up to 5 months
|
2.1%
3/143 • Number of events 3 • Up to 5 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
6.2%
4/65 • Number of events 9 • Up to 5 months
|
2.1%
3/143 • Number of events 6 • Up to 5 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
67.7%
44/65 • Number of events 128 • Up to 5 months
|
69.2%
99/143 • Number of events 306 • Up to 5 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
23.1%
15/65 • Number of events 30 • Up to 5 months
|
21.0%
30/143 • Number of events 64 • Up to 5 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.9%
11/65 • Number of events 18 • Up to 5 months
|
14.7%
21/143 • Number of events 43 • Up to 5 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
1.5%
1/65 • Number of events 3 • Up to 5 months
|
1.4%
2/143 • Number of events 5 • Up to 5 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/65 • Up to 5 months
|
7.7%
11/143 • Number of events 23 • Up to 5 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/65 • Up to 5 months
|
1.4%
2/143 • Number of events 2 • Up to 5 months
|
|
Vascular disorders
Hot flashes
|
6.2%
4/65 • Number of events 15 • Up to 5 months
|
1.4%
2/143 • Number of events 4 • Up to 5 months
|
|
Vascular disorders
Hypertension
|
7.7%
5/65 • Number of events 20 • Up to 5 months
|
3.5%
5/143 • Number of events 11 • Up to 5 months
|
|
Vascular disorders
Lymphedema
|
1.5%
1/65 • Number of events 5 • Up to 5 months
|
2.1%
3/143 • Number of events 3 • Up to 5 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
1.5%
1/65 • Number of events 4 • Up to 5 months
|
0.00%
0/143 • Up to 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place