Topical Boswellia Serrata 2% to Prevent Radiation Dermatitis in Head and Neck Cancer

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
Background: Acute radiation‐induced dermatitis is a common adverse effect in patientsundergoing radiotherapy for head and neck cancer, and it can impair quality of life and,when severe, contribute to treatment interruptions. Boswellia serrata gum resin (Indianolibanum) has recognized anti‐inflammatory properties, and a topical boswellic‐acid creampreviously reduced skin‐reaction severity and the need for rescue corticosteroids inbreast radiotherapy. Evidence in head and neck cancer is lacking.Objective: To evaluate the efficacy of a 2% Boswellia serrata gum‐resin topical cream inpreventing or reducing acute radiation‐induced dermatitis in head and neck cancerpatients undergoing radiotherapy.Design: Non‐randomized (quasi‐experimental), open‐label, interventional study with twoparallel groups. The intervention group applies the 2% Boswellia cream to the radiationfield twice daily throughout radiotherapy; the control group receives no preventivetopical treatment (rescue treatment only if skin reactions occur). Planned enrollment is60 participants (about 30 per group), based on an a priori power analysis for thedifference 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 endof radiotherapy, and at 2 and 4 weeks after radiotherapy, using both the RTOG acuteradiation morbidity skin score and CTCAE v5.0. Patient‐reported pain, itching, andburning (numeric rating scales) and a skin‐related quality‐of‐life instrument arecollected. Rescue interventions, adverse events, and radiotherapy interruptions arelogged.Ethics: The study was approved by the Research Ethics Committee, Faculty of Medicine,Alexandria University (serial 0109668; IRB 00012098; FWA 00018699). Written informedconsent is obtained from every participant before enrollment.
Epistemonikos ID: 6e8d005ebcec31b210595e36f364fabad9670ef5
First added on: Aug 21, 2026