Testa appliceringen av Mepitel-film under strålbehandling för att minska strålningsrelaterad rodnad och peeling hos bröstcancerpatienter efter mastektomi
Mepitel-film för att minska strålningsdermatit hos bröstcancerpatienter som genomgår strålbehandling efter mastektomi: en randomiserad klinisk fas III-prövning
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
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California
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Marysville, California, Förenta staterna, 95901
- Fremont - Rideout Cancer Center
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Truckee, California, Förenta staterna, 96161
- Gene Upshaw Memorial Tahoe Forest Cancer Center
-
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Delaware
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Frankford, Delaware, Förenta staterna, 19945
- Beebe South Coastal Health Campus
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Newark, Delaware, Förenta staterna, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Förenta staterna, 19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach, Delaware, Förenta staterna, 19971
- Beebe Health Campus
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Florida
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Atlantis, Florida, Förenta staterna, 33462
- John Fitzgerald Kennedy Medical Center
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Iowa
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Ames, Iowa, Förenta staterna, 50010
- McFarland Clinic - Ames
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Cedar Rapids, Iowa, Förenta staterna, 52403
- Mercy Hospital
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Cedar Rapids, Iowa, Förenta staterna, 52403
- Oncology Associates at Mercy Medical Center
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Clive, Iowa, Förenta staterna, 50325
- Mercy Cancer Center-West Lakes
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Des Moines, Iowa, Förenta staterna, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Förenta staterna, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Förenta staterna, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Maine
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Bath, Maine, Förenta staterna, 04530
- MaineHealth Coastal Cancer Treatment Center
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Portland, Maine, Förenta staterna, 04102
- Maine Medical Center-Bramhall Campus
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Sanford, Maine, Förenta staterna, 04073
- MaineHealth Cancer Care Center of York County
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Scarborough, Maine, Förenta staterna, 04074
- Maine Medical Center- Scarborough Campus
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Maryland
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Annapolis, Maryland, Förenta staterna, 21401
- Anne Arundel Medical Center
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Baltimore, Maryland, Förenta staterna, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, Förenta staterna, 21201
- University of Maryland/Greenebaum Cancer Center
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Columbia, Maryland, Förenta staterna, 21044
- Central Maryland Radiation Oncology in Howard County
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Glen Burnie, Maryland, Förenta staterna, 21061
- UM Baltimore Washington Medical Center/Tate Cancer Center
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Towson, Maryland, Förenta staterna, 21204
- UM Saint Joseph Medical Center
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48106
- Saint Joseph Mercy Hospital
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Brighton, Michigan, Förenta staterna, 48114
- Saint Joseph Mercy Brighton
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Livonia, Michigan, Förenta staterna, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic in Rochester
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Missouri
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Rolla, Missouri, Förenta staterna, 65401
- Delbert Day Cancer Institute at PCRMC
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Springfield, Missouri, Förenta staterna, 65804
- Mercy Hospital Springfield
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St Louis, Missouri, Förenta staterna, 63141
- Mercy Hospital Saint Louis
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Montana
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Billings, Montana, Förenta staterna, 59101
- Billings Clinic Cancer Center
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New York
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Glens Falls, New York, Förenta staterna, 12801
- Glens Falls Hospital
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White Plains, New York, Förenta staterna, 10601
- Dickstein Cancer Treatment Center
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North Dakota
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Grand Forks, North Dakota, Förenta staterna, 58201
- Altru Cancer Center
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Pennsylvania
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Meadowbrook, Pennsylvania, Förenta staterna, 19046
- Holy Redeemer Hospital and Medical Center
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South Carolina
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Anderson, South Carolina, Förenta staterna, 29621
- AnMed Health Cancer Center
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Georgetown, South Carolina, Förenta staterna, 29440
- Tidelands Georgetown Memorial Hospital
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Greenville, South Carolina, Förenta staterna, 29607
- Saint Francis Cancer Center
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Greenville, South Carolina, Förenta staterna, 29601
- Saint Francis Hospital
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Greer, South Carolina, Förenta staterna, 29651
- Gibbs Cancer Center-Pelham
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Murrells Inlet, South Carolina, Förenta staterna, 29576
- MUSC Health Tidelands Health Radiation Therapy Center
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Spartanburg, South Carolina, Förenta staterna, 29303
- Spartanburg Medical Center
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Texas
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Laredo, Texas, Förenta staterna, 78041
- Doctor's Hospital of Laredo
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Utah
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Salt Lake City, Utah, Förenta staterna, 84112
- Huntsman Cancer Institute/University of Utah
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Salt Lake City, Utah, Förenta staterna, 84106
- University of Utah Sugarhouse Health Center
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Wisconsin
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Appleton, Wisconsin, Förenta staterna, 54911
- ThedaCare Regional Cancer Center
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Wausau, Wisconsin, Förenta staterna, 54401
- Aspirus Regional Cancer Center
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Wisconsin Rapids, Wisconsin, Förenta staterna, 54494
- Aspirus Cancer Care - Wisconsin Rapids
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Arm I (standard of care)
Patients receive standard of care skin management during radiation therapy for up to 6 weeks. |
Ancillary studies Ancillary studies Receive standard of care
Andra namn:
|
|
Experimentell: 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. |
Ancillary studies Ancillary studies Apply Mepitel Film |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Serially Measured Patient-completed Modified Radiation Induced Skin Reaction Assessment Scale (mRISRAS) Scores
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Kimberly Corbin, MD, Mayo Clinic
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Hudsjukdomar
- Bröstsjukdomar
- Hud- och bindvävssjukdomar
- Bröstneoplasmer
- Administration
- Sjukvårdskvalitet, tillgång och utvärdering
- Hälsovårdskvalitet
- Kvalitetsindikatorer, hälsovård
- Utrustning och förnödenheter
- Riktlinjer som ämne
- Kvalitetssäkring, hälsovård
- Vårdstandard
- Öva riktlinjer som ämne
- Förband
Andra studie-ID-nummer
- A221803
- UG1CA189823 (U.S.S. NIH-anslag/kontrakt)
- NCI-2019-04688 (Registeridentifierare: NCI Clinical Trial Reporting Program)
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