Recruiting
Phase 2

Skin Care Approaches

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07918989

Conditions

Breast Cancer

Breast Cancer Female

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mometasone Furoate 1% Cream

Mepitel Film

Intranasal mupirocin

Chlorhexidine body cleansing

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Breast Cancer Female

Study ID

NCT07918989

Start date

Oct 30, 2026

Status verified date

Oct, 2026

Completion date

Oct 30, 2028

Anticipated

Primary completion date

Oct 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

138 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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

experimental: 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.

experimental: Arm 3: Bacterial decolonization

Bacterial decolonization (BD) is a intervention that has been studied as an ARD prevention measure.

Interventions

Mometasone Furoate 1% Cream

Mometasone Furoate 1% Cream is a topical corticosteroid cream

Mepitel Film

Mepitel Film is a transparent film with a contact layer with silicone adhesion.

Intranasal mupirocin

Bacterial decolonization (BD) regimen involves a 5 day regimen of twice-daily intranasal mupirocin and chlorhexidine body cleansing

Chlorhexidine body cleansing

Bacterial decolonization (BD) regimen involves a 5 day regimen of twice-daily intranasal mupirocin and chlorhexidine body cleansing

Primary outcome measure

  • Rate of acute radiation dermatitis with most desquamation (ARD-MD) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Isabelle Choi, MD

646-449-1997

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Isabelle Choi, MD

646-449-1997

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Isabelle Choi, MD

646-449-1997

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )

Recruiting

Commack, New York, United States, 11725

Contacts

Isabelle Choi, MD

646-449-1997

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Isabelle Choi, MD

646-449-1997

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

Recruiting

New York, New York, United States, 10065

Contacts

Isabelle Choi, MD

646-449-1997

Memorial Sloan Kettering Nassau (All protocol activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Isabelle Choi, MD

646-449-1997

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Nov 5, 2026

Last verified

Oct, 2026

Keywords

  • Breast Cancer
  • Breast Cancer Female
  • Memorial Sloan Kettering Cancer Center
  • 26-356

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.