Head and Neck Neoplasms, Radiodermatitis
Conditions
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.
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.
Interventions
DRUGBoswellia 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.
Sponsors
Youssef Hashem Hafez
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rescue treatment requirement | From start of radiotherapy through 4 weeks after completion of radiotherapy (up to approximately 11 weeks) | 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). |
| Improvement in skin condition (change-of-condition assessment) | At the end of radiotherapy (approximately 7 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to onset of radiodermatitis | From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks) | Time (days) from the start of radiotherapy to the first occurrence of a grade 1 or higher skin reaction (RTOG/CTCAE). |
| Maximum severity of radiodermatitis | From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks) | Highest radiodermatitis grade recorded during the study, assessed using the RTOG acute radiation morbidity skin score and CTCAE v5.0. |
| Patient-reported skin symptoms | Weekly, from start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks) | Weekly patient-reported pain, itching, and burning of the treated skin, each rated on a 0-10 numeric rating scale. |
| Radiotherapy interruptions due to skin toxicity | During radiotherapy (approximately 7 weeks) | Number and duration (days) of radiotherapy interruptions or missed fractions attributable to skin toxicity. |
| Incidence of adverse events (safety and tolerability) | From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks) | Incidence of local and systemic adverse events, including allergic contact dermatitis, associated with daily application of the study cream. |
Countries
Egypt
Contacts
CONTACTYoussef Hashem Hafez
Outcome results
None listed