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Testing av påføring av Mepitel-film under strålebehandling for å redusere strålingsrelatert rødhet og peeling hos brystkreftpasienter etter mastektomi

27. august 2026 oppdatert av: Alliance for Clinical Trials in Oncology

Mepitel-film for reduksjon av strålingsdermatitt hos brystkreftpasienter som gjennomgår strålebehandling etter mastektomi: en randomisert fase III klinisk studie

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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 as needed or once every 2 weeks 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, 2 years, then every 6 months up to 5 years.

Studietype

Intervensjonell

Registrering (Faktiske)

216

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Marysville, California, Forente stater, 95901
        • Fremont - Rideout Cancer Center
      • Truckee, California, Forente stater, 96161
        • Gene Upshaw Memorial Tahoe Forest Cancer Center
    • Delaware
      • Frankford, Delaware, Forente stater, 19945
        • Beebe South Coastal Health Campus
      • Newark, Delaware, Forente stater, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Forente stater, 19713
        • Medical Oncology Hematology Consultants PA
      • Rehoboth Beach, Delaware, Forente stater, 19971
        • Beebe Health Campus
    • Florida
      • Atlantis, Florida, Forente stater, 33462
        • John Fitzgerald Kennedy Medical Center
    • Iowa
      • Ames, Iowa, Forente stater, 50010
        • McFarland Clinic - Ames
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Oncology Associates at Mercy Medical Center
      • Clive, Iowa, Forente stater, 50325
        • Mercy Cancer Center-West Lakes
      • Des Moines, Iowa, Forente stater, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Forente stater, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Forente stater, 50309
        • Medical Oncology and Hematology Associates-Des Moines
    • Maine
      • Bath, Maine, Forente stater, 04530
        • MaineHealth Coastal Cancer Treatment Center
      • Portland, Maine, Forente stater, 04102
        • Maine Medical Center-Bramhall Campus
      • Sanford, Maine, Forente stater, 04073
        • MaineHealth Cancer Care Center of York County
      • Scarborough, Maine, Forente stater, 04074
        • Maine Medical Center- Scarborough Campus
    • Maryland
      • Annapolis, Maryland, Forente stater, 21401
        • Anne Arundel Medical Center
      • Baltimore, Maryland, Forente stater, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, Forente stater, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Columbia, Maryland, Forente stater, 21044
        • Central Maryland Radiation Oncology in Howard County
      • Glen Burnie, Maryland, Forente stater, 21061
        • UM Baltimore Washington Medical Center/Tate Cancer Center
      • Towson, Maryland, Forente stater, 21204
        • UM Saint Joseph Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48106
        • Saint Joseph Mercy Hospital
      • Brighton, Michigan, Forente stater, 48114
        • Saint Joseph Mercy Brighton
      • Livonia, Michigan, Forente stater, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic in Rochester
    • Missouri
      • Rolla, Missouri, Forente stater, 65401
        • Delbert Day Cancer Institute at PCRMC
      • Springfield, Missouri, Forente stater, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Forente stater, 63141
        • Mercy Hospital Saint Louis
    • Montana
      • Billings, Montana, Forente stater, 59101
        • Billings Clinic Cancer Center
    • New York
      • Glens Falls, New York, Forente stater, 12801
        • Glens Falls Hospital
      • White Plains, New York, Forente stater, 10601
        • Dickstein Cancer Treatment Center
    • North Dakota
      • Grand Forks, North Dakota, Forente stater, 58201
        • Altru Cancer Center
    • Pennsylvania
      • Meadowbrook, Pennsylvania, Forente stater, 19046
        • Holy Redeemer Hospital and Medical Center
    • South Carolina
      • Anderson, South Carolina, Forente stater, 29621
        • AnMed Health Cancer Center
      • Georgetown, South Carolina, Forente stater, 29440
        • Tidelands Georgetown Memorial Hospital
      • Greenville, South Carolina, Forente stater, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, Forente stater, 29601
        • Saint Francis Hospital
      • Greer, South Carolina, Forente stater, 29651
        • Gibbs Cancer Center-Pelham
      • Murrells Inlet, South Carolina, Forente stater, 29576
        • MUSC Health Tidelands Health Radiation Therapy Center
      • Spartanburg, South Carolina, Forente stater, 29303
        • Spartanburg Medical Center
    • Texas
      • Laredo, Texas, Forente stater, 78041
        • Doctor's Hospital of Laredo
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, Forente stater, 84106
        • University of Utah Sugarhouse Health Center
    • Wisconsin
      • Appleton, Wisconsin, Forente stater, 54911
        • ThedaCare Regional Cancer Center
      • Wausau, Wisconsin, Forente stater, 54401
        • Aspirus Regional Cancer Center
      • Wisconsin Rapids, Wisconsin, Forente stater, 54494
        • Aspirus Cancer Care - Wisconsin Rapids

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.
  • Age >= 18 years.
  • 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Arm I (standard of care)

Patients receive standard of care skin management during radiation therapy for up to 6 weeks.
Annen: Quality-of-Life Assessment

Ancillary studies

Annen: Questionnaire Administration

Ancillary studies

Annen: Best Practice

Receive standard of care

Andre navn:
  • Velferdstandard
Eksperimentell: Arm II (Mepitel Film)

Patients receive Mepitel Film applied to breast or chest wall every 2 weeks before radiation therapy for up to 6 weeks.
Annen: Quality-of-Life Assessment

Ancillary studies

Annen: Questionnaire Administration

Ancillary studies

Enhet: Wound Dressing Material

Apply Mepitel Film

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
Tidsramme: 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.
Up to 5 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 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.
Up to 2 months
Serially Measured Non-blinded Institutional Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
Tidsramme: 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.
Up to 5 months
Serially Measured Combined Patient- and Provider-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
Tidsramme: 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.
Up to 5 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Kimberly Corbin, MD, Mayo Clinic

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. juli 2022

Primær fullføring (Faktiske)

29. mai 2024

Studiet fullført (Antatt)

15. februar 2029

Datoer for studieregistrering

Først innsendt

26. juli 2021

Først innsendt som oppfylte QC-kriteriene

26. juli 2021

Først lagt ut (Faktiske)

4. august 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A221803
  • UG1CA189823 (U.S. NIH-stipend/kontrakt)
  • NCI-2019-04688 (Registeridentifikator: NCI Clinical Trial Reporting Program)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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