Topical Boswellia Serrata 2% to Prevent Radiation Dermatitis in Head and Neck Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYoussef Hashem Hafez
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Boswellia serrata 2% topical cream
DrugA cream containing 2% Boswellia serrata (Indian olibanum) gum resin, applied to the radiation field twice daily throughout the radiotherapy course.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Boswellia 2% CreamExperimental treatment 1 intervention
Group B: Control (No Preventive Treatment)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
From start of radiotherapy through 4 weeks after completion of radiotherapy (up to approximately 11 weeks)2
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.
Time frame
At the end of radiotherapy (approximately 7 weeks)Secondary outcomes
1
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).
Time frame
From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)2
Maximum severity of radiodermatitis
Highest radiodermatitis grade recorded during the study, assessed using the RTOG acute radiation morbidity skin score and CTCAE v5.0.
Time frame
From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)3
Patient-reported skin symptoms
Weekly patient-reported pain, itching, and burning of the treated skin, each rated on a 0-10 numeric rating scale.
Time frame
Weekly, from start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)4
Radiotherapy interruptions due to skin toxicity
Number and duration (days) of radiotherapy interruptions or missed fractions attributable to skin toxicity.
Time frame
During radiotherapy (approximately 7 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Youssef Hashem Hafez
Lead sponsor
Alexandria University
Sponsor institution
Source ClinicalTrials.gov