NCT07918989 · Memorial Sloan Kettering Cancer Center
A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After Mastectomy
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Mometasone Furoate 1% Cream
Mometasone Furoate 1% Cream is a topical corticosteroid cream
DEVICE
Mepitel Film
Mepitel Film is a transparent film with a contact layer with silicone adhesion.
DIETARY_SUPPLEMENT
Intranasal mupirocin
Bacterial decolonization (BD) regimen involves a 5 day regimen of twice-daily intranasal mupirocin and chlorhexidine body cleansing
OTHER
Chlorhexidine body cleansing
Bacterial decolonization (BD) regimen involves a 5 day regimen of twice-daily intranasal mupirocin and chlorhexidine body cleansing
Primary outcome measures
Rate of acute radiation dermatitis with most desquamation (ARD-MD)
Time frame: 12 months
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- ECOG Performance Status of ≤ 2
Exclusion criteria
- Patients with indication for escalated skin dose (dermal invasion, skin involvement, positive surgical margin).
- Patients planned to receive a scar or chest wall, or other boost.
- Patients planned to receive post-mastectomy radiotherapy using a hypofractionated regimen (ie., \>2.0 Gy per fraction).
- Patients who have a diagnosis of connective tissue disorder or collagen vascular disorder.
- Patients who have an active rash in the cervical or thoracic region.
- Patients taking systemic steroids \>10 mg/day.
- Patients on active antimicrobial treatment at the time of study enrollment.
- Patients with a prior history of organ or bone marrow transplant.
- Patients who are pregnant or nursing
- 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).
- Comorbid conditions: o Active infection requiring parenteral antibiotic(s)
- 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.
- 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).
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Rockville Centre, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 5, 2026 · Source of record for eligibility and locations