Testing the Application of Mepitel Film During Radiation... | NCT04989504

ID	Type	Description	Link
NCI-2019-04688	Registry Identifier	NCI Clinical Trial Reporting Program
UG1CA189823	U.S. NIH Grant/Contract		View source

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Label	Type	Description	Intervention Names
Arm I (standard of care)	Active Comparator	Patients receive standard of care skin management during radiation therapy for up to 6 weeks.	Other: Best Practice Other: Quality-of-Life Assessment Other: Questionnaire Administration
Arm II (Mepitel Film)	Experimental	Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.	Device: Wound Dressing Material Other: Quality-of-Life Assessment Other: Questionnaire Administration

Name	Type	Description	Arm Group Labels	Other Names
Best Practice	Other	Receive standard of care	Arm I (standard of care)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Up to 5 months

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Name	Affiliation	Role
Kimberly Corbin, MD	Mayo Clinic	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Fremont - Rideout Cancer Center		Marysville	California	95901	United States
Gene Upshaw Memorial Tahoe Forest Cancer Center

ID	Title	Description
FG000	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
FG001	Arm II (Mepitel Film)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 4, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Posted

Median

95% Confidence Interval

score on a scale*month

Up to 5 months

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG00060 OG001132

Title

Denominators

Categories

Title	Measurements
	OG00046.24(38.42 to 54.06) OG00135.32(29.40 to 41.23)

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.

Not Posted

Up to 2 months

Participants

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.

Posted

Median

Full Range

score on a scale*month

Up to 5 months

ID	Title	Description
OG000	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
OG001	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

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.

Posted

Median

Full Range

score on a scale*month

Up to 5 months

ID	Title	Description
OG000	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
OG001	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

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymph node pain	Blood and lymphatic system disorders	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0013 events2 affected143 at risk
Pericardial effusion	Cardiac disorders	CTCAE 5	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected143 at risk
Constipation	Gastrointestinal disorders	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0012 events2 affected143 at risk
Diarrhea	Gastrointestinal disorders	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected143 at risk
Dysphagia	Gastrointestinal disorders	CTCAE 5	Systematic Assessment	EG0001 events1 affected65 at risk EG0016 events4 affected143 at risk
Esophagitis	Gastrointestinal disorders	CTCAE 5	Systematic Assessment	EG0001 events1 affected65 at risk EG00120 events8 affected143 at risk
Nausea	Gastrointestinal disorders	CTCAE 5	Systematic Assessment	EG00018 events8 affected65 at risk EG00118 events8 affected143 at risk
Vomiting	Gastrointestinal disorders	CTCAE 5	Systematic Assessment	EG0002 events1 affected65 at risk EG0010 events0 affected143 at risk
Edema limbs	General disorders	CTCAE 5	Systematic Assessment	EG0001 events1 affected65 at risk EG0011 events1 affected143 at risk
Fatigue	General disorders	CTCAE 5	Systematic Assessment	EG00058 events18 affected65 at risk EG00180 events33 affected143 at risk
Fever	General disorders	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected143 at risk
Localized edema	General disorders	CTCAE 5	Systematic Assessment	EG00010 events3 affected65 at risk EG00122 events9 affected143 at risk
Non-cardiac chest pain	General disorders	CTCAE 5	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected143 at risk
Pain	General disorders	CTCAE 5	Systematic Assessment	EG0002 events2 affected65 at risk EG00110 events5 affected143 at risk
Infections and infestations - Oth spec	Infections and infestations	CTCAE 5	Systematic Assessment	EG0001 events1 affected65 at risk EG0013 events2 affected143 at risk
Shingles	Infections and infestations	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0012 events1 affected143 at risk
Skin infection	Infections and infestations	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG00114 events8 affected143 at risk
Urinary tract infection	Infections and infestations	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected143 at risk
Dermatitis radiation	Injury, poisoning and procedural complications	CTCAE 5	Systematic Assessment	EG000211 events56 affected65 at risk EG001351 events115 affected143 at risk
Seroma	Injury, poisoning and procedural complications	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG00110 events2 affected143 at risk
Wound complication	Injury, poisoning and procedural complications	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0015 events1 affected143 at risk
Lymphocyte count decreased	Investigations	CTCAE 5	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected143 at risk
Neutrophil count decreased	Investigations	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected143 at risk
Weight loss	Investigations	CTCAE 5	Systematic Assessment	EG0002 events1 affected65 at risk EG0010 events0 affected143 at risk
White blood cell decreased	Investigations	CTCAE 5	Systematic Assessment	EG0004 events1 affected65 at risk EG0011 events1 affected143 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE 5	Systematic Assessment	EG0003 events2 affected65 at risk EG0015 events4 affected143 at risk
Hyperlipidemia	Metabolism and nutrition disorders	CTCAE 5	Systematic Assessment	EG0006 events1 affected65 at risk EG0010 events0 affected143 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE 5	Systematic Assessment	EG0004 events1 affected65 at risk EG0019 events4 affected143 at risk
Bone pain	Musculoskeletal and connective tissue disorders	CTCAE 5	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected143 at risk
Fibrosis deep connective tissue	Musculoskeletal and connective tissue disorders	CTCAE 5	Systematic Assessment	EG0003 events1 affected65 at risk EG0010 events0 affected143 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	CTCAE 5	Systematic Assessment	EG0004 events3 affected65 at risk EG0012 events1 affected143 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	CTCAE 5	Systematic Assessment	EG0008 events2 affected65 at risk EG0010 events0 affected143 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE 5	Systematic Assessment	EG0008 events2 affected65 at risk EG0010 events0 affected143 at risk
Superficial soft tissue fibrosis	Musculoskeletal and connective tissue disorders	CTCAE 5	Systematic Assessment	EG0007 events3 affected65 at risk EG0013 events3 affected143 at risk
Headache	Nervous system disorders	CTCAE 5	Systematic Assessment	EG0002 events1 affected65 at risk EG0011 events1 affected143 at risk
Memory impairment	Nervous system disorders	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0013 events1 affected143 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAE 5	Systematic Assessment	EG0005 events3 affected65 at risk EG00110 events3 affected143 at risk
Anxiety	Psychiatric disorders	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0013 events3 affected143 at risk
Insomnia	Psychiatric disorders	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0016 events2 affected143 at risk
Chronic kidney disease	Renal and urinary disorders	CTCAE 5	Systematic Assessment	EG0006 events1 affected65 at risk EG0010 events0 affected143 at risk
Breast pain	Reproductive system and breast disorders	CTCAE 5	Systematic Assessment	EG00026 events9 affected65 at risk EG00126 events8 affected143 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE 5	Systematic Assessment	EG0004 events3 affected65 at risk EG0011 events1 affected143 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE 5	Systematic Assessment	EG0001 events1 affected65 at risk EG0011 events1 affected143 at risk
Hoarseness	Respiratory, thoracic and mediastinal disorders	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected143 at risk
Postnasal drip	Respiratory, thoracic and mediastinal disorders	CTCAE 5	Systematic Assessment	EG0003 events1 affected65 at risk EG0010 events0 affected143 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	CTCAE 5	Systematic Assessment	EG0003 events1 affected65 at risk EG0011 events1 affected143 at risk
Alopecia	Skin and subcutaneous tissue disorders	CTCAE 5	Systematic Assessment	EG00012 events2 affected65 at risk EG00110 events3 affected143 at risk
Dry skin	Skin and subcutaneous tissue disorders	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG00124 events9 affected143 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	CTCAE 5	Systematic Assessment	EG0001 events1 affected65 at risk EG0013 events3 affected143 at risk
Pain of skin	Skin and subcutaneous tissue disorders	CTCAE 5	Systematic Assessment	EG0009 events4 affected65 at risk EG0016 events3 affected143 at risk
Pruritus	Skin and subcutaneous tissue disorders	CTCAE 5	Systematic Assessment	EG000128 events44 affected65 at risk EG001306 events99 affected143 at risk
Rash acneiform	Skin and subcutaneous tissue disorders	CTCAE 5	Systematic Assessment	EG00030 events15 affected65 at risk EG00164 events30 affected143 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE 5	Systematic Assessment	EG00018 events11 affected65 at risk EG00143 events21 affected143 at risk
Skin and subcut tissue disord - Oth spec	Skin and subcutaneous tissue disorders	CTCAE 5	Systematic Assessment	EG0003 events1 affected65 at risk EG0015 events2 affected143 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG00123 events11 affected143 at risk
Urticaria	Skin and subcutaneous tissue disorders	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0012 events2 affected143 at risk
Hot flashes	Vascular disorders	CTCAE 5	Systematic Assessment	EG00015 events4 affected65 at risk EG0014 events2 affected143 at risk
Hypertension	Vascular disorders	CTCAE 5	Systematic Assessment	EG00020 events5 affected65 at risk EG00111 events5 affected143 at risk
Lymphedema	Vascular disorders	CTCAE 5	Systematic Assessment	EG0005 events1 affected65 at risk EG0013 events3 affected143 at risk
Vascular disorders - Other, specify	Vascular disorders	CTCAE 5	Systematic Assessment	EG0004 events1 affected65 at risk EG0010 events0 affected143 at risk

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D017410	Practice Guidelines as Topic
D059039	Standard of Care
D001458	Bandages

ID	Term
D017408	Guidelines as Topic
D011785	Quality Assurance, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation
D019984	Quality Indicators, Health Care
D004864	Equipment and Supplies

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm I (Standard of Care)	Questionnaire Administration: Ancillary studies	0	65	2	65	59	65
EG001	Arm II (Mepitel Film)	Questionnaire Administration: Ancillary studies	0	143	7	143	133	143

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lung infection	Infections and infestations	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected143 at risk
Sepsis	Infections and infestations	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected143 at risk
Dermatitis radiation	Injury, poisoning and procedural complications	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0012 events2 affected143 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	CTCAE 5	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected143 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected143 at risk
Pruritus	Skin and subcutaneous tissue disorders	CTCAE 5	Systematic Assessment	EG0001 events1 affected65 at risk EG0013 events3 affected143 at risk
Hypertension	Vascular disorders	CTCAE 5	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected143 at risk