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Testare l'applicazione della pellicola Mepitel durante la radioterapia per ridurre l'arrossamento e la desquamazione correlati alle radiazioni nei pazienti affetti da cancro al seno dopo mastectomia

27 agosto 2026 aggiornato da: Alliance for Clinical Trials in Oncology

Film Mepitel per la riduzione della dermatite da radiazioni nelle pazienti con carcinoma mammario sottoposte a radioterapia post-mastectomia: uno studio clinico randomizzato di fase III

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

216

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Arm I (standard of care)

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

Ancillary studies

Altro: Questionnaire Administration

Ancillary studies

Altro: Best Practice

Receive standard of care

Altri nomi:
  • Standard di sicurezza
Sperimentale: 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.
Altro: Quality-of-Life Assessment

Ancillary studies

Altro: Questionnaire Administration

Ancillary studies

Dispositivo: Wound Dressing Material

Apply Mepitel Film

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Cattedra di studio: Kimberly Corbin, MD, Mayo Clinic

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 luglio 2022

Completamento primario (Effettivo)

29 maggio 2024

Completamento dello studio (Stimato)

15 febbraio 2029

Date di iscrizione allo studio

Primo inviato

26 luglio 2021

Primo inviato che soddisfa i criteri di controllo qualità

26 luglio 2021

Primo Inserito (Effettivo)

4 agosto 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A221803
  • UG1CA189823 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2019-04688 (Identificatore di registro: NCI Clinical Trial Reporting Program)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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