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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Neoplasms; Radiodermatitis
• Intervention / Treatment: Drug: Boswellia serrata 2% topical cream

Detailed Description

Background: Acute radiation-induced dermatitis is a common adverse effect in patients undergoing radiotherapy for head and neck cancer, and it can impair quality of life and, when severe, contribute to treatment interruptions. Boswellia serrata gum resin (Indian olibanum) has recognized anti-inflammatory properties, and a topical boswellic-acid cream previously reduced skin-reaction severity and the need for rescue corticosteroids in breast radiotherapy. Evidence in head and neck cancer is lacking.

Objective: To evaluate the efficacy of a 2% Boswellia serrata gum-resin topical cream in preventing or reducing acute radiation-induced dermatitis in head and neck cancer patients undergoing radiotherapy.

Design: Non-randomized (quasi-experimental), open-label, interventional study with two parallel groups. The intervention group applies the 2% Boswellia cream to the radiation field twice daily throughout radiotherapy; the control group receives no preventive topical treatment (rescue treatment only if skin reactions occur). Planned enrollment is 60 participants (about 30 per group), based on an a priori power analysis for the difference in rescue-treatment requirement between groups.

Setting: Alexandria University Main Hospitals and Ayady Almostakbal Hospital, Egypt.

Assessments: Skin toxicity is graded at baseline, weekly during radiotherapy, at the end of radiotherapy, and at 2 and 4 weeks after radiotherapy, using both the RTOG acute radiation morbidity skin score and CTCAE v5.0. Patient-reported pain, itching, and burning (numeric rating scales) and a skin-related quality-of-life instrument are collected. Rescue interventions, adverse events, and radiotherapy interruptions are logged.

Ethics: The study was approved by the Research Ethics Committee, Faculty of Medicine, Alexandria University (serial 0109668; IRB 00012098; FWA 00018699). Written informed consent is obtained from every participant before enrollment.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youssef Hashem Hafez; Phone Number: +20 110 007 9619; Email: youssefhashem17@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria university main hospitals
  • Alexandria, Egypt
    • Recruiting
    • Ayady Almostakbal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Boswellia 2% Cream; Topical Boswellia serrata 2% gum-resin cream applied to the radiation field twice daily throughout the radiotherapy course.	Drug: Boswellia serrata 2% topical cream; A cream containing 2% Boswellia serrata (Indian olibanum) gum resin, applied to the radiation field twice daily throughout the radiotherapy course.
No Intervention: Control (No Preventive Treatment); No preventive topical treatment during radiotherapy; usual care, with rescue treatment provided only if skin reactions occur.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to onset of radiodermatitis	Time (days) from the start of radiotherapy to the first occurrence of a grade 1 or higher skin reaction (RTOG/CTCAE).	From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Maximum severity of radiodermatitis	Highest radiodermatitis grade recorded during the study, assessed using the RTOG acute radiation morbidity skin score and CTCAE v5.0.	From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Patient-reported skin symptoms	Weekly patient-reported pain, itching, and burning of the treated skin, each rated on a 0-10 numeric rating scale.	Weekly, from start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Radiotherapy interruptions due to skin toxicity	Number and duration (days) of radiotherapy interruptions or missed fractions attributable to skin toxicity.	During radiotherapy (approximately 7 weeks)
Incidence of adverse events (safety and tolerability)	Incidence of local and systemic adverse events, including allergic contact dermatitis, associated with daily application of the study cream.	From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)

Collaborators and Investigators

• Sponsor: Youssef Hashem Hafez

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: August 18, 2026
• First Posted (Actual): August 21, 2026

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 18, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Neoplasms by Site; Neoplasms; Skin Diseases; Radiation Injuries; Dermatitis; Skin and Connective Tissue Diseases; Head and Neck Neoplasms; Radiodermatitis; Polymers; Macromolecular Substances; Biological Products; Complex Mixtures; Biopolymers; Plant Exudates; Resins, Plant; Frankincense
• Other Study ID Numbers: BOSWELLIA-RD-HNC-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No