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Bacterial Decolonization for the Prevention of Radiation Dermatitis in Patients with Breast or Head and Neck Cancer Receiving Radiotherapy

Trial Status: Active

This phase II / III trial studies the effect of decreasing bacteria on the skin (bacterial decolonization) before treatment with radiation in preventing radiation dermatitis in patients with breast or head and neck cancer. Radiation dermatitis is a common rash that can occur from radiation therapy. Previous study showed that people who have bacteria in their nose prior to initiation of radiotherapy have an increased risk of developing radiation dermatitis. Bacterial decolonization may prevent high-grade radiation dermatitis and improve quality of life during radiotherapy in patients with breast or head and neck cancer.

Inclusion Criteria

  • Age >= 18
  • Diagnosis of a solid tumor of the breast or head and neck with plans for fractionated RT (>= 15 fractions) with curative intent, including post-operative patients deemed eligible for RT by their surgeons and radiation oncologists

Exclusion Criteria

  • Prior RT to the region of interest
  • Existing dermatologic condition affecting the treatment area (eg: atopic dermatitis, psoriasis, and non-healing wounds)
  • Known allergy to chlorhexidine or mupirocin

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: ACTIVE
Contact: Beth Mclellan
Phone: 718-920-2680

PRIMARY OBJECTIVE:

I. To determine if bacterial decolonization prior to radiotherapy (RT) prevents development of high grade radiation dermatitis (RD) (grade 2-5).

SECONDARY OBJECTIVE:

I. To assess if the intervention improves quality of life compared to the control arm.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Prior to start of radiation therapy, patients receive mupirocin ointment intranasally twice daily (BID) and use chlorhexidine gluconate body wash once daily (QD) for 5 days and at weeks 2, 4, 6, and 8 of radiation therapy in the absence of unacceptable toxicity.

ARM II: Patients receive standard of care.

Trial Phase Phase II/III

Trial Type Prevention

Lead Organization
Montefiore Medical Center-Weiler Hospital

Principal Investigator
Beth Mclellan

  • Primary ID 2018-9722
  • Secondary IDs NCI-2021-02745
  • Clinicaltrials.gov ID NCT03883828