NCT07778290 Topical Boswellia Serrata 2% to Prevent Radiation Dermatitis in Head and Neck Cancer
| NCT ID | NCT07778290 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Youssef Hashem Hafez |
| Condition | Head and Neck Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-08-18 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-08-18 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: \- 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: \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07778290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07778290 currently recruiting?
Yes, NCT07778290 is actively recruiting participants. Contact the research team at youssefhashem17@gmail.com for enrollment information.
Where is the NCT07778290 trial being conducted?
This trial is being conducted at Alexandria, Egypt, Alexandria, Egypt.
Who is sponsoring the NCT07778290 clinical trial?
NCT07778290 is sponsored by Youssef Hashem Hafez. The trial plans to enroll 60 participants.