Different skin care approaches to prevent skin reactions after mastectomy radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial compares three skin care strategies—Mometasone Furoate 1% cream, Mepitel Film, and chlorhexidine body cleansing, with or without mupirocin—to prevent dermatitis from post-mastectomy radiation therapy. Eligible participants are adults with pathologically confirmed breast cancer who have had mastectomy and are planned for comprehensive radiotherapy to the chest wall and regional nodes. The study uses randomized or parallel assignment to assess which approach most effectively reduces skin reactions, with safety and tolerability monitored throughout treatment. Location is MSK facilities in New Jersey, including Basking Ridge, Monmouth, and Bergen sites.

Why it matters

Who can join: the full rules

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:

* 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.
* 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).

Where it's running

• Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (All Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (All Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (All Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activites)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Isabelle Choi, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Isabelle Choi, MD
• Email: choij3@mskcc.org
• Phone: 646-449-1997

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.