Breast Carcinoma, Mastectomy Patient
Conditions
Brief summary
This phase III trial studies how well Mepitel Film works in reducing radiation dermatitis (redness and peeling) in patients with breast cancer during radiation therapy after a mastectomy. Mepitel Film may reduce the severity of skin redness and peeling in the area of radiation.
Detailed description
The primary and secondary objectives of the study: PRIMARY OBJECTIVES: I. To determine the ability of Mepitel Film to reduce the severity of radiation dermatitis in patients undergoing post-mastectomy radiotherapy for breast cancer when compared to the institutional standard of care. KEY SECONDARY OBJECTIVES: I. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a centralized, blinded provider assessment review of photographs. II. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a non-blinded institutional provider assessment. III. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a combined patient and non-blinded institutional provider assessment. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive standard of care skin management during radiation therapy for up to 6 weeks. ARM II: Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks. After completion of study, patients are followed up at 7-14 days, 3 months, 6 months, 1 year, and 2 years.
Interventions
OTHERBest Practice
Receive standard of care
DEVICEWound Dressing Material
Apply Mepitel Film
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic confirmation of breast malignancy with TNM staging. * Patients must have undergone a mastectomy with or without reconstruction within the past 120 days if not receiving adjuvant therapy, or within 60 days after completion of the last dose of chemotherapy. * No prior radiotherapy to any portion of the planned treatment site. * No documented history of adhesive or tape allergy. * Patients must be scheduled to receive conventionally fractionated photon-based radiation. Patients planning brachytherapy within the treatment field, and patients scheduled to receive bilateral radiation or hypofractionated radiation are not eligible. * No active rash or pre-existing dermatitis within the treatment field. * No co-existing medical conditions resulting in life expectancy \< 2 years. * No active collagen vascular diseases (i.e. lupus erythematosus, scleroderma, dermatomyositis). * No concomitant cytotoxic chemotherapy. Endocrine therapy and HER2 directed therapies are allowed. * No current inflammatory breast cancer, or gross dermal involvement at initiation of radiotherapy. * No previous history of organ or bone marrow transplant. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * In order to complete the mandatory patient-completed measures, participants must be able to speak and read English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores | Up to 5 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Centralized, Blinded Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores Obtained From a Blinded Grading of the Photographs Taken at the End of Radiation Therapy | Up to 2 months | At 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. |
| Serially Measured Non-blinded Institutional Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores | Up to 5 months | 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 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. |
| Serially Measured Combined Patient- and Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores | Up to 5 months | 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 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 73 |
| 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 | 143 |
| Total | 216 |
Baseline characteristics
| Characteristic | Total | Arm II (Mepitel Film) | Arm I (Standard of Care) |
|---|---|---|---|
| Age, Continuous | 53 years | 53 years | 53 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 9 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 195 Participants | 129 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 5 Participants | 2 Participants |
| Ever Received Boost No | 169 Participants | 116 Participants | 53 Participants |
| Ever Received Boost Yes | 47 Participants | 27 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 14 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 181 Participants | 123 Participants | 58 Participants |
| Sex: Female, Male Female | 213 Participants | 142 Participants | 71 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 143 |
| other Total, other adverse events | 59 / 65 | 133 / 143 |
| serious Total, serious adverse events | 2 / 65 | 7 / 143 |
Outcome results
Primary
Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
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.
Time frame: Up to 5 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Standard of Care) | Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores | 46.24 score on a scale*month |
| Arm II (Mepitel Film) | Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores | 35.32 score on a scale*month |
Secondary
Centralized, Blinded Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores Obtained From a Blinded Grading of the Photographs Taken at the End of Radiation Therapy
At 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.
Time frame: Up to 2 months
Secondary
Serially Measured Combined Patient- and Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
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 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.
Time frame: Up to 5 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Standard of Care) | Serially Measured Combined Patient- and Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores | 16.0 score on a scale*month |
| Arm II (Mepitel Film) | Serially Measured Combined Patient- and Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores | 16.0 score on a scale*month |
Secondary
Serially Measured Non-blinded Institutional Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
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 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.
Time frame: Up to 5 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Standard of Care) | Serially Measured Non-blinded Institutional Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores | 8.0 score on a scale*month |
| Arm II (Mepitel Film) | Serially Measured Non-blinded Institutional Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores | 8.0 score on a scale*month |