Head and Neck NeoplasmsNCT07778290
Topical Boswellia Serrata 2% to Prevent Radiation Dermatitis in Head and Neck Cancer
A study testing Boswellia serrata 2% topical cream in people with Head and Neck Neoplasms and Radiodermatitis, run by Youssef Hashem Hafez at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Radiodermatitis
- What is being tested?
- Boswellia serrata 2% topical cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 18 Aug 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy or breastfeeding
- Any other condition that, in the investigator's judgment, would compromise participation or confound the results
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Alexandria University Main Hospitals
Alexandria
- Recruiting
Ayady Almostakbal Hospital
Alexandria
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Neoplasms, Radiodermatitis
- Being tested
- Boswellia serrata 2% topical cream
- Medical subject headings
- Head and Neck Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boswellia serrata 2% topical creamDrug
A cream containing 2% Boswellia serrata (Indian olibanum) gum resin, applied to the radiation field twice daily throughout the radiotherapy course.
| Study group | Role | What they receive |
|---|---|---|
| Boswellia 2% Cream | Experimental | Topical Boswellia serrata 2% gum-resin cream applied to the radiation field twice daily throughout the radiotherapy course. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: At the end of radiotherapy (approximately 7 weeks)
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start18 Aug 2026
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Youssef Hashem Hafez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Youssef Hashem Hafez, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778290
- Sponsor's protocol ID
- BOSWELLIA-RD-HNC-2026
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Boswellia Serrata Roxb. Gum Resin 2% Cream for the Prevention of Radiation-Induced Dermatitis in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT07778290
- Acronym / sponsor ID
- BOSWELLIA-RD-HNC-2026
- Conditions
- Head and Neck Neoplasms, Radiodermatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Youssef Hashem HafezUniversity, hospital or other
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boswellia 2% Cream | Experimental | Drug: Boswellia serrata 2% topical creamTopical Boswellia serrata 2% gum-resin cream applied to the radiation field twice daily throughout the radiotherapy course. |
| Control (No Preventive Treatment) | No intervention | –No preventive topical treatment during radiotherapy; usual care, with rescue treatment provided only if skin reactions occur. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boswellia serrata 2% topical creamA cream containing 2% Boswellia serrata (Indian olibanum) gum resin, applied to the radiation field twice daily throughout the radiotherapy course. | Drug | Boswellia 2% Cream |
Primary outcome
Rescue treatment requirement
Time frame: 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)
Time frame: 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.
5 secondary outcomes
Time to onset of radiodermatitis
Time frame: From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Maximum severity of radiodermatitis
Time frame: From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Patient-reported skin symptoms
Time frame: Weekly, from start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Radiotherapy interruptions due to skin toxicity
Time frame: During radiotherapy (approximately 7 weeks)
Incidence of adverse events (safety and tolerability)
Time frame: From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boswellia serrata 2% topical cream in people with Head and Neck Neoplasms and Radiodermatitis, run by Youssef Hashem Hafez at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youssef Hashem Hafez (+20 110 007 9619, youssefhashem17@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rescue treatment requirement (time frame: From start of radiotherapy through 4 weeks after completion of radiotherapy (up to approximately 11 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.