Topical Boswellia Serrata 2% to Prevent Radiation Dermatitis in Head and Neck Cancer

Topical Boswellia Serrata Roxb. Gum Resin 2% Cream for the Prevention of Radiation-Induced Dermatitis in Head and Neck Cancer Patients

This study evaluates a topical 2% Boswellia serrata (Indian olibanum) gum-resin cream for the prevention of acute radiation-induced dermatitis in patients with head and neck cancer undergoing radiotherapy. Participants in the intervention group apply the cream to the radiation field twice daily throughout the radiotherapy course; the control group receives no preventive topical treatment (rescue treatment only if skin reactions occur). The two co-primary outcomes are the proportion of patients who require rescue treatment (e.g., topical corticosteroids or other topical interventions) for skin reactions, and the proportion whose skin condition is rated "improved" or "in remission" versus "unchanged" or "worsened" on a standardized change-of-condition assessment. Secondary outcomes include time to onset of radiodermatitis, maximal severity (RTOG and CTCAE grading), patient-reported symptoms (pain, itching, burning) and quality of life, radiotherapy interruptions due to skin toxicity, and safety/tolerability.

Inclusion Criteria:

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Inclusion Criteria:

• Adults aged 18 years or older, of any sex, with histologically confirmed head and neck cancer for which radiotherapy is indicated
• Planned external-beam radiotherapy to the head and neck region (curative or adjuvant intent) with a planned total dose of at least 60 Gy; concurrent chemotherapy is permitted
• Able to provide written informed consent and comply with the protocol (twice-daily cream application, follow-up visits, and a skin diary)
• Agreement to avoid other topical treatments in the radiation field during the study period (except study-provided or allowed rescue medication)

Exclusion Criteria:

• Previous radiotherapy to the same site
• Previous extensive surgery or reconstruction in the head and neck region that substantially alters the radiation field or interferes with skin assessment
• Known allergy or hypersensitivity to Boswellia serrata, boswellic acids, or any component of the cream base
• Current use of systemic corticosteroids or anti-inflammatory medications that could influence skin reactions (low-dose corticosteroids as chemotherapy premedication are allowed)
• Dermatologic conditions in the treatment area that could interfere with assessment (e.g., psoriasis, scleroderma, severe acne, chronic wounds)
• Pre-existing dermatitis or significant skin lesions in the radiation field at baseline
• Pregnancy or breastfeeding
• Any other condition that, in the investigator's judgment, would compromise participation or confound the results

Exclusion Criteria:

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