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

NCT07778290 | Recruiting

• 1 other identifier: BOSWELLIA-RD-HNC-2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Neoplasms; Radiodermatitis

Outcome Measures

Primary Outcomes (2)

• Rescue treatment requirement

  Proportion of participants who require any rescue medication beyond the study cream to manage skin reactions (most importantly topical corticosteroids, but also oral analgesics, antibiotics, or wound care).

  From start of radiotherapy through 4 weeks after completion of radiotherapy (up to approximately 11 weeks)

• Improvement in skin condition (change-of-condition assessment)

  Proportion of participants whose skin condition is rated 'improved' or 'in remission' versus 'unchanged' or 'worsened' on a standardized change-of-condition assessment (adapted from psoriasis/eczema studies) at the end of radiotherapy.

  At the end of radiotherapy (approximately 7 weeks)

Secondary Outcomes (5)

• Time to onset of radiodermatitis

  From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)

• Maximum severity of radiodermatitis

  From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)

• Patient-reported skin symptoms

  Weekly, from start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)

• Radiotherapy interruptions due to skin toxicity

  During radiotherapy (approximately 7 weeks)

• Incidence of adverse events (safety and tolerability)

  From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)

Study Arms (2)

Boswellia 2% Cream

EXPERIMENTAL

Topical Boswellia serrata 2% gum-resin cream applied to the radiation field twice daily throughout the radiotherapy course.

Drug: Boswellia serrata 2% topical cream

Control (No Preventive Treatment)

NO INTERVENTION

No preventive topical treatment during radiotherapy; usual care, with rescue treatment provided only if skin reactions occur.

Interventions

Boswellia serrata 2% topical cream DRUG

A cream containing 2% Boswellia serrata (Indian olibanum) gum resin, applied to the radiation field twice daily throughout the radiotherapy course.

Boswellia 2% Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Youssef Hashem Hafez: lead

Study Sites (2)

Alexandria University Main Hospitals

Alexandria, Egypt

RECRUITING

Ayady Almostakbal Hospital

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Radiodermatitis

Interventions

Frankincense

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Central Study Contacts

Youssef Hashem Hafez

CONTACT

+20 110 007 9619; youssefhashem17@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start: August 18, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Locations

EG (2)