NCT07778290Recruiting
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 18 Aug 2026
- Start date
- 18 Aug 2026
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Youssef Hashem Hafez
- Diseases
- Head and neck cancer
- NCT number
- NCT07778290
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 18 Aug 2026 to the primary completion date, 31 Oct 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Current use of systemic corticosteroids or anti-inflammatory medications that could influence skin reactions (low-dose corticosteroids as chemotherapy premedication are allowed)
- Pre-existing dermatitis or significant skin lesions in the radiation field at baseline
Other illness
- Known allergy or hypersensitivity to Boswellia serrata, boswellic acids, or any component of the cream base
- Dermatologic conditions in the treatment area that could interfere with assessment (e.g., psoriasis, scleroderma, severe acne, chronic wounds)
- Any other condition that, in the investigator's judgment, would compromise participation or confound the results
Other
- Pregnancy or breastfeeding
- \-
Who the study is looking for
- \-
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ayady Almostakbal Hospital Coordinator of this site? Confirm its status | Alexandria | Egypt | Recruiting |
| Alexandria University Main Hospitals Coordinator of this site? Confirm its status | Alexandria | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.