An interventional study of Boswellia serrata 2% topical cream in Head and Neck Neoplasms and Radiodermatitis, sponsored by Youssef Hashem Hafez. Recruiting at 2 sites in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Youssef Hashem Hafez · Not applicable, Interventional, and Prevention
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.
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 60 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →This is the only study on the registry with Youssef Hashem Hafez as lead sponsor.
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Inclusion Criteria:
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topical Boswellia serrata 2% gum-resin cream applied to the radiation field twice daily throughout the radiotherapy course.
Drug: Boswellia serrata 2% topical cream
No preventive topical treatment during radiotherapy; usual care, with rescue treatment provided only if skin reactions occur.
Drug page: Indian frankincense
A cream containing 2% Boswellia serrata (Indian olibanum) gum resin, applied to the radiation field twice daily throughout the radiotherapy course.
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)
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)
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)
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)
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)
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)
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.
Time frame: From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Oct 2027, 14 months after the start.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 14 months is below that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Indian frankincense