A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After Mastectomy
OPTimal Intervention for the Prevention of Radiation Dermatitis During Breast Cancer Post-Mastectomy Radiotherapy (OPTIC): A Parallel, Three-Arm, Phase II Open-Label Randomized Trial
The purpose of this study is to find out which of three standard skin care approaches works best to prevent a skin reaction called radiation dermatitis (redness, irritation, or breakdown of the skin) in people receiving radiation therapy after mastectomy.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Atif Khan, MD
- Telefonnummer: 848-225-6334
- E-post: khana7@mskcc.org
Studer Kontakt Backup
- Navn: Isabelle Choi, MD
- Telefonnummer: 646-449-1997
- E-post: choij3@mskcc.org
Studiesteder
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New Jersey
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Basking Ridge, New Jersey, Forente stater, 07920
- Rekruttering
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
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Ta kontakt med:
- Isabelle Choi, MD
- Telefonnummer: 646-449-1997
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Middletown, New Jersey, Forente stater, 07748
- Rekruttering
- Memorial Sloan Kettering Monmouth (All Protocol Activities)
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Ta kontakt med:
- Isabelle Choi, MD
- Telefonnummer: 646-449-1997
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Montvale, New Jersey, Forente stater, 07645
- Rekruttering
- Memorial Sloan Kettering Bergen (All Protocol Activities)
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Ta kontakt med:
- Isabelle Choi, MD
- Telefonnummer: 646-449-1997
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New York
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Commack, New York, Forente stater, 11725
- Rekruttering
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
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Ta kontakt med:
- Isabelle Choi, MD
- Telefonnummer: 646-449-1997
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Harrison, New York, Forente stater, 10604
- Rekruttering
- Memorial Sloan Kettering Westchester (All Protocol Activities)
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Ta kontakt med:
- Isabelle Choi, MD
- Telefonnummer: 646-449-1997
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New York, New York, Forente stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center (All Protocol Activites)
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Ta kontakt med:
- Isabelle Choi, MD
- Telefonnummer: 646-449-1997
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Rockville Centre, New York, Forente stater, 11553
- Rekruttering
- Memorial Sloan Kettering Nassau (All protocol activities)
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Ta kontakt med:
- Isabelle Choi, MD
- Telefonnummer: 646-449-1997
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients must have pathologically confirmed breast cancer.
- Patients will have an assigned sex of female at birth.
- Patients will have undergone mastectomy without breast reconstruction surgery or with immediate reconstruction using one or more of an expander, implant, or flap-based approach.
- Patients will have pathologic stage T1-3 N0-1 M0 disease with indication for comprehensive post-mastectomy radiotherapy to the ipsilateral chest wall and regional lymph node basins (axilla, SCV, IMN).
- Patient/LAR willing to sign and date consent form
- Age ≥ 18
- ECOG Performance Status of ≤ 2
Exclusion Criteria:
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Patients with indication for escalated skin dose (dermal invasion, skin involvement, positive surgical margin).
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Patients planned to receive a scar or chest wall, or other boost.
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Patients planned to receive post-mastectomy radiotherapy using a hypofractionated regimen (ie., >2.0 Gy per fraction).
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Patients who have a diagnosis of connective tissue disorder or collagen vascular disorder.
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Patients who have an active rash in the cervical or thoracic region.
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Patients taking systemic steroids >10 mg/day.
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Patients on active antimicrobial treatment at the time of study enrollment.
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Patients with a prior history of organ or bone marrow transplant.
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Patients who are pregnant or nursing
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Prior Treatment:
- Patients with prior history of radiotherapy to the neck, thorax or abdomen.
- Resolution of all toxicities of prior therapy or surgical procedures to baseline or Grade 1 (except for hypothyroidism requiring medication, which must have resolved to Grade ≤2, alopecia, and other toxicities considered clinically nonsignificant and/or stable on supportive therapy as determined by the investigator).
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Comorbid conditions:
o Active infection requiring parenteral antibiotic(s)
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Concomitant Medications:
o Concurrent systemic therapy during the course are not allowed, including cytotoxic chemotherapy, immunotherapy, and targeted therapy. Last dose of these agents must be delivered at least 2 weeks prior to start of radiotherapy and not to be restarted until at least 2 weeks following completion of radiotherapy. Endocrine therapy, pembrolizumab, Herceptin, Perjeta, and Kadcyla are allowed. Concurrent oral steroid medications are not allowed.
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Allergies:
- History of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Arm 1: Mometasone furoate
An ARD prevention strategy that has demonstrated the ability to reduce significant radiation dermatitis during breast radiotherapy is the topical application of corticosteroid creams, including mometasone and betametasone |
Mometasone Furoate 1% Cream is a topical corticosteroid cream |
|
Eksperimentell: Arm 2: Mepitel Film
The use of barrier films such as Mepitel Film, Hydrofilm, and StrataXRT, has also been demonstrated to be effective in reducing the risk of clinically significant ARD. |
Mepitel Film is a transparent film with a contact layer with silicone adhesion. |
|
Eksperimentell: Arm 3: Bacterial decolonization
Bacterial decolonization (BD) is a intervention that has been studied as an ARD prevention measure. |
Bacterial decolonization (BD) regimen involves a 5 day regimen of twice-daily intranasal mupirocin and chlorhexidine body cleansing Bacterial decolonization (BD) regimen involves a 5 day regimen of twice-daily intranasal mupirocin and chlorhexidine body cleansing |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of acute radiation dermatitis with most desquamation (ARD-MD)
Tidsramme: 12 months
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To evaluate the rate of acute radiation dermatitis with moist desquamation (ARD-MD) using three acute radiation dermatitis (ARD) prevention strategies compared with historical rates using standard of care strategies in patients receiving post-mastectomy radiotherapy (PMRT). |
12 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Isabelle Choi, MD, Memorial Sloan Kettering Cancer Center
Publikasjoner og nyttige lenker
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Studierekorddatoer
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Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
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Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26-356
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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