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

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 interventional, open-label study tests whether applying a 2% Boswellia serrata gum-resin cream to the radiation field twice daily during radiotherapy reduces acute dermatitis. Participants are assigned to either receive the Boswellia cream or no preventive topical treatment (rescue meds allowed if skin reactions occur). The study uses two co-primary outcomes: need for rescue treatment for skin reactions and whether skin condition improves or remains the same versus worsens. Secondary outcomes include time to dermatitis onset, peak severity by standard toxicity scales, patient-reported symptoms, quality of life, and radiotherapy interruptions due to skin toxicity. Enrollment targets 60 participants across two Egyptian hospitals, with weekly skin assessments through and after radiotherapy.

Why it matters

Who can join: the full rules

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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Where it's running

• Alexandria University Main Hospitals
  Alexandria, Egypt Recruiting
• Ayady Almostakbal Hospital
  Alexandria, Egypt Recruiting

Study contacts

• Study coordinator: Youssef Hashem Hafez
• Email: youssefhashem17@gmail.com
• Phone: +20 110 007 9619

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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.