New Research on Bacterial Decolonization and Radiation Dermatitis

New research found that bacterial decolonization is safe and more efficacious for reducing the effect of acute radiation dermatitis than the standard of care in patients undergoing treatment for cancer. The study results were published in the journal JAMA Oncology.

Radiation therapy (RT) following breast-conserving cancer surgery lowers cancer-related mortality and recurrence. However, acute radiation dermatitis (ARD) within weeks after starting radiotherapy, such as severe skin erythema, dryness, moist or dry desquamation, and/or ulceration, may interrupt radiotherapy. Literature shows that bacterial decolonization (BD) decreases the severity of acute radiation dermatitis (ARD) for patients with cancer receiving radiation therapy compared with the standard of care. Hence, researchers from Albert Einstein College of Medicine, Bronx, New York, conducted a randomized clinical trial to determine the efficacy of bacterial decolonization (BD) on ARD severity compared with the standard of care.

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A phase 2/3 randomized clinical trial was conducted from June 2019 to August 2021 with investigator blinding at an urban academic cancer center by enrolling patients with breast cancer or head and neck cancer receiving radiation therapy (RT) with curative intent. Nearly 123 patients were assessed for eligibility via convenience sampling, 3 were excluded, and 40 refused to participate. Interventions included intranasal mupirocin ointment twice a day along with chlorhexidine body cleanser once daily for 5 days before RT and repeated for 5 days every 2 weeks through RT. The primary outcome was the development of grade 2 or higher ARD with moist desquamation.

Key Findings

• About 80 patients volunteered for the trial.
• Of 77 patients with cancer, there were 75 patients with breast cancer (97.4%) and 2 patients with head and neck cancer (2.6%) who completed RT.
• Among these, 39 were randomly assigned BD, and 38 were randomly assigned standard of care; the mean (SD) age of the patients was 59.9 (11.9) years, and 75 (97.4%) were female. Most patients were Black or Hispanic.
• Out of the total patients with breast and head and neck cancer, none of the 39 patients treated with BD, and about 9 of the 38 patients (23.7%) treated with standard of care developed ARD grade 2-MD or higher.
• Similar results were seen among the 75 patients with breast cancer.
• The mean (SD) ARD grade was significantly lower for patients treated with BD.
• Of the 39 patients randomly assigned to BD, 27 (69.2%) reported regimen adherence, and only 1 patient (2.5%) experienced an adverse event related to BD (i.e., itch).

Thus, bacterial decolonization was found to be effective for ARD prophylaxis mainly for breast cancer patients.

Further reading: Kost Y, Deutsch A, Mieczkowska K, et al. Bacterial Decolonization for Prevention of Radiation Dermatitis: A Randomized Clinical Trial [published online ahead of print, 2023 May 4]. JAMA Oncol. 2023;10.1001/jamaoncol.2023.0444. doi: 10.1001/jamaoncol.2023.0444