An interventional study of Fragrance-Free Emollient (Glycerol-Based); A fragrance-free, glycerol-based emollient applied to the skin from day 1 of TomoTherapy. and Mepitel Film (Silicone-Based Semi-Permeable Barrier Film) in Head and Neck Cancer, sponsored by King Faisal Specialist Hospital & Research Center. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by King Faisal Specialist Hospital & Research Center · Not applicable, Interventional, and Prevention
Background/Introduction; Head and neck cancers (HNC) are frequently treated with definitive radiotherapy or chemoradiotherapy, which are effective modalities for tumor control and organ preservation. However, these treatments are often associated with significant acute toxicities, particularly incidence of radiation dermatitis which is as high as 84%. Radiation-induced skin reactions are typically classified as acute, consequential-late, or chronic, with acute dermatitis being the most immediate and impactful during treatment. Studies reveal that acute radiation-dermatitis (ARD) occur within 24 hours but usually begin within days to weeks of initiating radiotherapy and is responsible for discomfort, pain, aesthetic changes, increased risk of infection, and potentially, treatment interruptions, thereby affecting both the patient's quality of life and therapeutic outcomes.
Hypothesis
Methodology This is a prospective, randomized, controlled, two-arm clinical trial evaluating strategies to mitigate radiation-induced skin toxicity in head and neck cancer (HNC) patients undergoing TomoTherapy.
Design:
Parallel-group design with 1:1 allocation using computer-generated block randomization, stratified by chemotherapy status.
Masking:
Open-label design; outcome assessors (radiation oncologists grading dermatitis) will be blinded where feasible.
Sample Size:
Approximately 104 patients (52 per arm) to detect a 20% absolute reduction in Grade ≥2 dermatitis incidence (from 55% to 35%) with 80% power and α = 0.05, accounting for 10% attrition.
Data Collection:
Weekly (Day 1,7,14,21,28,35) CTCAE skin assessments documented in MOSAIQ. QoL instruments (EORTC QLQ-C30 v3 and QLQ-HN35) administered at Baseline (Day 1), mid-treatment (Day 17), and end-of-treatment (Day 35).
Clinical and treatment data recorded in an encrypted Excel database.
Ethical Considerations:
All participants receive at least standard of care (STDoC). Written informed consent required prior to radiotherapy. Data are anonymized and securely stored.
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 104 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
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Exclusion Criteria:
Participants in Arm A will receive standard treatment during TomoTherapy (STDoC) plus a fragrance-free, glycerol-based emollient applied to skin starting day 1 of treatment. If participants develop Grade ≥2 radiation dermatitis, an absorbent polyurethane foam dressing (PolyMem-equivalent) will be applied to the affected area. This arm serves as the active comparator for evaluating the efficacy of the experimental intervention (Mepitel).
Other: Fragrance-Free Emollient (Glycerol-Based); A fragrance-free, glycerol-based emollient applied to the skin from day 1 of TomoTherapy.
A silicone-based semi-permeable barrier film applied to the skin from day 1 of TomoTherapy. Evaluated as the experimental intervention to prevent or reduce radiation-induced skin toxicity.
Device: Mepitel Film (Silicone-Based Semi-Permeable Barrier Film)
A foam dressing applied to areas of Grade ≥2 radiation dermatitis for skin protection during TomoTherapy. Part of Arm A.
A silicone-based semi-permeable barrier film applied to the skin from day 1 of TomoTherapy. Evaluated as the experimental intervention to prevent or reduce radiation-induced skin toxicity.
Number of patients developing Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≥2 dermatitis by completion of radiotherapy.
Clinical evaluation of radiation-induced dermatitis will be measured using the Common Terminology Criteria for Adverse Events (CTCAE) version \[v5.0\], focusing specifically on radiation dermatitis grading (21). * Radiation dermatitis will be assessed weekly (Day 7,14,21,28,35) by the attending radiation oncologist throughout the course of treatment, with documentation in MOSAIQ (radiation oncology information system) of onset, peak severity, and any treatment-related complications or interruptions. * CTCAE grading will be used to classify skin reactions as follows: * Grade 1: Faint erythema or dry desquamation * Grade 2: Moderate to brisk erythema; patchy moist desquamation mostly in skin folds * Grade 3: Moist desquamation in non-skin-fold areas; bleeding with minor trauma * Grade 4: Skin necrosis or ulceration of full-thickness dermis * Grade 5: Death (extremely rare in this context)
Time frame: Day 7,14,21,28,35 of radiotherapy for all patients registered in the study
-Number of days to start of Grade ≥2 dermatitis between arms.
Clinical evaluation of radiation-induced dermatitis will be measured using the Common Terminology Criteria for Adverse Events (CTCAE) version \[v5.0\], focusing specifically on radiation dermatitis grading (21). * Radiation dermatitis will be assessed weekly (Day 1,7,14,21,28,35) by the attending radiation oncologist throughout the course of treatment, with documentation in MOSAIQ (radiation oncology information system) of onset, peak severity, and any treatment-related complications or interruptions. * CTCAE grading will be used to classify skin reactions as follows: * Grade 1: Faint erythema or dry desquamation * Grade 2: Moderate to brisk erythema; patchy moist desquamation mostly in skin folds * Grade 3: Moist desquamation in non-skin-fold areas; bleeding with minor trauma * Grade 4: Skin necrosis or ulceration of full-thickness dermis * Grade 5: Death (extremely rare in this context)
Time frame: Day 7,14,21,28,35 during the course of radiotherapy
Number of patients with maximum dermatitis grade during treatment.
Number of patients with maximum dermatitis grade during treatment.
Time frame: Day 7, 14, 21, 28, 35 of radiotherapy
Number of patients with incidence of moist desquamation.
Incidence of moist desquamation will be assessed weekly by the attending radiation oncologist throughout the course of treatment, with documentation in MOSAIQ (radiation oncology information system)
Time frame: Day 7, 14, 21, 28, 35 of radiotherapy treatment
Number of patients with treatment interruptions >3 days due to skin toxicity.
Any interruptions in radiotherapy treatment \>3 days due to skin toxicity
Time frame: From beginning to end of radiotherapy treatment (Day 1 to Day 35)
Patient-reported outcomes from EORTC QLQ-HN35 for each participant
* The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) H\&N35 is a questionnaire developed specifically for patients with head and neck cancer. It includes 35 questions grouped into 7 subscales covering pain, swallowing, senses (taste/smell), speech, social eating, social contact, and sexuality. * In addition, there are 10 individual items addressing issues such as dental problems, dry mouth, coughing, difficulty opening the mouth, sticky saliva, weight loss or gain, use of nutritional supplements, feeding tubes, and pain medication. * Interpretation of scores: Scores are from 1 to 4, where 1 reflects "not at all" and 4 is "very much". Higher scores on the functional and global health scales indicate better functioning and well-being, whereas higher scores on the symptom scales reflect greater symptom burden or difficulty.
Time frame: At baseline (Day 1), mid-treatment (Day 17) at end of radiotherapy treatment (Day 35).
Global health/quality of life impact (QLQ-C30) for every participant
• The European Organisation for Research and Treatment of Cancer (EORTC) QLQ C30. This questionnaire includes 30 items, that describe 5 functioning scales (physical, role, emotional, cognitive, and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items symptoms (dyspnoea, insomnia, loss of appetite, constipation, diarrhoea, and financial difficulties). Interpretation of scores. Scores are from 1 to 4, where 1 reflects "not at all" and 4 is "very much". Higher scores on the symptom scales reflect greater symptom burden or difficulty.
Time frame: At baseline (Day 1), mid-treatment (Day 17) at end of radiotherapy treatment (Day 35).
No study locations are listed for this record.
Plan to share: Undecided
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King Faisal Specialist Hospital & Research Center