Head and Neck CancerMCTPUTNCT07357506
Reducing Skin Side Effects in Patients Receiving Radiation on Tomotherapy
A study testing 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 people with Head and Neck Cancer, run by King Faisal Specialist Hospital & Research Center.
Trial summary
Radiation dermatitis is a common side effect in head and neck cancer (HNC) patients receiving radiotherapy, especially with advanced techniques like TomoTherapy. The use of 6 MegaVoltage (MV) Flattening Filter-Free (FFF) beams and shorter Source to Skin Distance (SSD) in TomoTherapy may increase skin dose, leading to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- 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)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Jan 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 with newly diagnosed head and neck (H\&N) carcinoma (confirmed by pathology)
- Must be receiving radiotherapy using Tomotherapy
Who cannot join
- Prior H\&N radiotherapy
- pre-existing skin disease
- allergy to study products.
About this study
Official title: Mitigating Cutaneous Toxicity in Patients Undergoing TomoTherapy; A Randomized Controlled Trial of Skin-Protective Strategies
- Radiation dermatitis is a common side effect in head and neck cancer (HNC) patients receiving radiotherapy, especially with advanced techniques like TomoTherapy. The use of 6 MegaVoltage (MV) Flattening Filter-Free (FFF) beams and shorter Source to Skin Distance (SSD) in TomoTherapy may increase skin dose, leading to higher rates of skin reactions such as redness, irritation, and pain. These reactions can affect patient comfort, increase the risk of infection, and even interrupt treatment.
- Although radiation dermatitis is frequent, there is no widely accepted standard for preventing or managing it. Supportive care programs, like the Dermatitis Control Program (DeCoP), and other supportive care programs using silicone-based semi-permeable barrier film have shown that simple measures-such as good skin hygiene and keeping the skin moist, can help reduce skin damage during treatment.
- This study will evaluate the effectiveness of fragrance-free emollient (glycerol-based) + absorbent polyurethane foam dressing versus silicone-based semi-permeable barrier film dressing in preventing or reducing skin toxicity in HNC patients receiving TomoTherapy. These products are easy to apply, affordable, and widely available, making them practical options for routine care.
Read the detailed description
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.
- Despite the clinical burden of radiation dermatitis, there is currently no universally accepted standard for its prevention or management. Established evidence supports the effectiveness of simplified, supportive care approaches, such as the Dermatitis Control Program (DeCoP), which focus on basic skin hygiene and maintaining a moist wound-healing environment during radiotherapy. This program demonstrated favorable outcomes in managing radiation dermatitis in patients with head and neck cancer.
- Clinical studies demonstrated that Moisturized skin care effectively reduced the severity and delayed the onset of radiation dermatitis, while also slowing down the decrease in skin moisture during radiotherapy.
- Additionally, barrier films such as Mepitel Film have shown promise in reducing ARD severity and moist desquamation. Systematic reviews and feasibility trials report benefit in breast and head/neck cancer patients. Including Mepitel Film as a comparator allows direct head-to-head testing of two evidence-based, guideline-consistent strategies.
- TomoTherapy, is a highly conformal and image-guided intensity-modulated radiotherapy (IMRT) technique. The system has shorter Source to Skin Distance (SSD) of 85cm and uses 6 MegaVoltage (MV) Flattening Filter-Free (FFF) energy which will increase the low energy photon contribution. Subsequently, one of the common side effects associated with this treatment is cutaneous toxicity, which can lead to skin irritation, erythema, and ulceration.
Hypothesis
- Use of fragrance-free emollient with absorbent dressing OR silicone barrier film, will reduce the severity of acute radiation dermatitis (ARD) with differential effects between interventions.
- While ARD significantly impacts patient well-being and clinical outcomes, standardized preventive care protocols remain inconsistent or under-researched in TomoTherapy. This study addresses that gap by evaluating a practical, low-cost intervention- fragrance-free emollient (glycerol-based) from day 1 + absorbent polyurethane foam dressing versus silicone-based semi-permeable barrier film applied from day 1-for its effectiveness in reducing skin toxicity and improving patient quality of life during TomoTherapy.
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Fragrance-Free Emollient (Glycerol-Based); A fragrance-free, glycerol-based emollient applied to the skin from day 1 of TomoTherapy., Mepitel Film (Silicone-Based Semi-Permeable Barrier Film)
- Keywords
- Head and Neck Cancer, Radiotherapy, Dermatitis
- Medical subject headings
- Head and Neck Neoplasms, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fragrance-Free Emollient (Glycerol-Based); A fragrance-free, glycerol-based emollient applied to the skin from day 1 of TomoTherapy.Other
A foam dressing applied to areas of Grade ≥2 radiation dermatitis for skin protection during TomoTherapy. Part of Arm A.
Mepitel Film (Silicone-Based Semi-Permeable Barrier Film)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: STDoC + fragrance-free emollient (glycerol-based) from day 1 + absorbent polyurethane foam dr | Active comparator | 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). Receives: Other: Fragrance-Free Emollient (Glycerol-Based); A fragrance-free, glycerol-based emollient applied to the skin from day 1 of TomoTherapy. |
| Arm B: STDoC + silicone-based semi-permeable barrier film (Mepitel Film-equivalent) applied from day | Experimental | 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. Receives: Device: Mepitel Film (Silicone-Based Semi-Permeable Barrier Film) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 7,14,21,28,35 of radiotherapy for all patients registered in the study
Secondary outcomes (6)
-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)
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: At baseline (Day 1), mid-treatment (Day 17) at end of radiotherapy treatment (Day 35).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in parallel groups to receive either Mepitel or a fragrance-free emollient as a skin-protective strategy during TomoTherapy. Each participant will receive only one of the two interventions throughout the study period, and outcomes will be compared between groups.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaheeda Mulla, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357506
- Sponsor's protocol ID
- RAC#: 2251649
- Acronym
- MCTPUT
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bjordal K, Hammerlid E, Ahlner-Elmqvist M, de Graeff A, Boysen M, Evensen JF, Biorklund A, de Leeuw JR, Fayers PM, Jannert M, Westin T, Kaasa S. Quality of life in head and neck cancer patients: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. J Clin Oncol. 1999 Mar;17(3):1008-19. doi: 10.1200/JCO.1999.17.3.1008.
PubMed 10071296Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PubMed 8433390Tayyib NA. Prophylactic Use of Mepitel(R) Film to Prevent Radiation-Induced Moist Desquamation in Cancer Patients. Cureus. 2023 Jul 20;15(7):e42186. doi: 10.7759/cureus.42186. eCollection 2023 Jul.
PubMed 37601988Wong HCY, Lee SF, Caini S, Chan AW, Kwan JYY, Waddle M, Sonis S, Herst P, Alcorn S, Bonomo P, Wong C, Corbin K, Choi JI, Rembielak A, AlKhaifi M, Marta GN, Rades D, van den Hurk C, Wolf JR, Chan RJ, Schmeel LC, Lock M, Hijal T, Cao J, Kim H, Chow E. Barrier films or dressings for the prevention of acute radiation dermatitis in breast cancer: a systematic review and network meta-analysis. Breast Cancer Res Treat. 2024 Oct;207(3):477-496. doi: 10.1007/s10549-024-07435-2. Epub 2024 Aug 7.
PubMed 39112742Yee C, Lam E, Gallant F, Karam I, Czarnota G, Soliman H, Wong G, Drost L, Vesprini D, Rakovitch E, Wronski M, Leung E, Szumacher E, Carothers K, Pon K, Gonzales G, Easton L, Lewis D, Zhang L, Chow E. A Feasibility Study of Mepitel Film for the Prevention of Breast Radiation Dermatitis in a Canadian Center. Pract Radiat Oncol. 2021 Jan-Feb;11(1):e36-e45. doi: 10.1016/j.prro.2020.09.004. Epub 2020 Sep 17.
PubMed 32949772Fernandez-Castro M, Martin-Gil B, Pena-Garcia I, Lopez-Vallecillo M, Garcia-Puig ME. Effectiveness of semi-permeable dressings to treat radiation-induced skin reactions. A systematic review. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12685. Epub 2017 Apr 18.
PubMed 28417508Iacovelli NA, Torrente Y, Ciuffreda A, Guardamagna VA, Gentili M, Giacomelli L, Sacerdote P. Topical treatment of radiation-induced dermatitis: current issues and potential solutions. Drugs Context. 2020 Jun 12;9:2020-4-7. doi: 10.7573/dic.2020-4-7. eCollection 2020.
PubMed 32587626Tsai PC, Liu YC, Li TS, Hsu FT, Lee YH, Chiang IT, Chang Y, Lee CH. Clinical Effect of Moisturized Skin Care on Radiation Dermatitis of Head and Neck Cancer. In Vivo. 2023 Nov-Dec;37(6):2776-2785. doi: 10.21873/invivo.13389.
PubMed 37905662Zenda S, Ishi S, Kawashima M, Arahira S, Tahara M, Hayashi R, Kishimoto S, Ichihashi T. A Dermatitis Control Program (DeCoP) for head and neck cancer patients receiving radiotherapy: a prospective phase II study. Int J Clin Oncol. 2013 Apr;18(2):350-5. doi: 10.1007/s10147-012-0385-9. Epub 2012 Feb 15.
PubMed 22350025Zenda S, Ishi S, Akimoto T, Arahira S, Motegi A, Tahara M, Hayashi R, Asanuma C. DeCoP, a Dermatitis Control Program using a moderately absorbent surgical pad for head and neck cancer patients receiving radiotherapy: a retrospective analysis. Jpn J Clin Oncol. 2015 May;45(5):433-8. doi: 10.1093/jjco/hyv010. Epub 2015 Feb 11.
PubMed 25673153Agnihotri V, Kshirsagar AY. To assess the incidence of radiation dermatitis among the cancer patients receiving radiotherapy. Int J Nurs Med Invest. 2018;3(3):107-110.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Cutaneous Toxicity in Patients Undergoing TomoTherapy; A Randomized Controlled Trial of Skin-Protective Strategies
- ClinicalTrials.gov ID
- NCT07357506
- Acronym / sponsor ID
- MCTPUT / RAC#: 2251649
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Radiotherapy, Dermatitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 22 Jan 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.
- Radiation dermatitis is a common side effect in head and neck cancer (HNC) patients receiving radiotherapy, especially with advanced techniques like TomoTherapy. The use of 6 MegaVoltage (MV) Flattening Filter-Free (FFF) beams and shorter Source to Skin Distance (SSD) in TomoTherapy may increase skin dose, leading to higher rates of skin reactions such as redness, irritation, and pain. These reactions can affect patient comfort, increase the risk of infection, and even interrupt treatment.
- Although radiation dermatitis is frequent, there is no widely accepted standard for preventing or managing it. Supportive care programs, like the Dermatitis Control Program (DeCoP), and other supportive care programs using silicone-based semi-permeable barrier film have shown that simple measures-such as good skin hygiene and keeping the skin moist, can help reduce skin damage during treatment.
- This study will evaluate the effectiveness of fragrance-free emollient (glycerol-based) + absorbent polyurethane foam dressing versus silicone-based semi-permeable barrier film dressing in preventing or reducing skin toxicity in HNC patients receiving TomoTherapy. These products are easy to apply, affordable, and widely available, making them practical options for routine care.
Detailed description
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.
- Despite the clinical burden of radiation dermatitis, there is currently no universally accepted standard for its prevention or management. Established evidence supports the effectiveness of simplified, supportive care approaches, such as the Dermatitis Control Program (DeCoP), which focus on basic skin hygiene and maintaining a moist wound-healing environment during radiotherapy. This program demonstrated favorable outcomes in managing radiation dermatitis in patients with head and neck cancer.
- Clinical studies demonstrated that Moisturized skin care effectively reduced the severity and delayed the onset of radiation dermatitis, while also slowing down the decrease in skin moisture during radiotherapy.
- Additionally, barrier films such as Mepitel Film have shown promise in reducing ARD severity and moist desquamation. Systematic reviews and feasibility trials report benefit in breast and head/neck cancer patients. Including Mepitel Film as a comparator allows direct head-to-head testing of two evidence-based, guideline-consistent strategies.
- TomoTherapy, is a highly conformal and image-guided intensity-modulated radiotherapy (IMRT) technique. The system has shorter Source to Skin Distance (SSD) of 85cm and uses 6 MegaVoltage (MV) Flattening Filter-Free (FFF) energy which will increase the low energy photon contribution. Subsequently, one of the common side effects associated with this treatment is cutaneous toxicity, which can lead to skin irritation, erythema, and ulceration.
Hypothesis
- Use of fragrance-free emollient with absorbent dressing OR silicone barrier film, will reduce the severity of acute radiation dermatitis (ARD) with differential effects between interventions.
- While ARD significantly impacts patient well-being and clinical outcomes, standardized preventive care protocols remain inconsistent or under-researched in TomoTherapy. This study addresses that gap by evaluating a practical, low-cost intervention- fragrance-free emollient (glycerol-based) from day 1 + absorbent polyurethane foam dressing versus silicone-based semi-permeable barrier film applied from day 1-for its effectiveness in reducing skin toxicity and improving patient quality of life during TomoTherapy.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in parallel groups to receive either Mepitel or a fragrance-free emollient as a skin-protective strategy during TomoTherapy. Each participant will receive only one of the two interventions throughout the study period, and outcomes will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Arm A: STDoC + fragrance-free emollient (glycerol-based) from day 1 + absorbent polyurethane foam dr | Active comparator | Other: Fragrance-Free Emollient (Glycerol-Based); A fragrance-free, glycerol-based emollient applied to the skin from day 1 of TomoTherapy.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). |
| Arm B: STDoC + silicone-based semi-permeable barrier film (Mepitel Film-equivalent) applied from day | Experimental | Device: Mepitel Film (Silicone-Based Semi-Permeable Barrier Film)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 to 80 with newly diagnosed head and neck (H\&N) carcinoma (confirmed by pathology)
- Must be receiving radiotherapy using Tomotherapy
Key exclusion criteria (3 listed)
- Prior H\&N radiotherapy
- pre-existing skin disease
- allergy to study products.
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 |
|---|---|---|
| Fragrance-Free Emollient (Glycerol-Based); A fragrance-free, glycerol-based emollient applied to the skin from day 1 of TomoTherapy.A foam dressing applied to areas of Grade ≥2 radiation dermatitis for skin protection during TomoTherapy. Part of Arm A. | Other | Arm A: STDoC + fragrance-free emollient (glycerol-based) from day 1 + absorbent polyurethane foam dr |
| Mepitel Film (Silicone-Based Semi-Permeable Barrier Film)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 | Arm B: STDoC + silicone-based semi-permeable barrier film (Mepitel Film-equivalent) applied from day |
Primary outcome
Number of patients developing Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≥2 dermatitis by completion of radiotherapy.
Time frame: Day 7,14,21,28,35 of radiotherapy for all patients registered in the study
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)
6 secondary outcomes
-Number of days to start of Grade ≥2 dermatitis between arms.
Time frame: Day 7,14,21,28,35 during the course of radiotherapy
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.
Time frame: Day 7, 14, 21, 28, 35 of radiotherapy treatment
Number of patients with treatment interruptions >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
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
Time frame: At baseline (Day 1), mid-treatment (Day 17) at end of radiotherapy treatment (Day 35).
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 22 Jan 2026.
- Background: PubMed 10071296Bjordal K, Hammerlid E, Ahlner-Elmqvist M, de Graeff A, Boysen M, Evensen JF, Biorklund A, de Leeuw JR, Fayers PM, Jannert M, Westin T, Kaasa S. Quality of life in head and neck cancer patients: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. J Clin Oncol. 1999 Mar;17(3):1008-19. doi: 10.1200/JCO.1999.17.3.1008.
- Background: PubMed 8433390Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
- Background: PubMed 37601988Tayyib NA. Prophylactic Use of Mepitel(R) Film to Prevent Radiation-Induced Moist Desquamation in Cancer Patients. Cureus. 2023 Jul 20;15(7):e42186. doi: 10.7759/cureus.42186. eCollection 2023 Jul.
- Background: PubMed 39112742Wong HCY, Lee SF, Caini S, Chan AW, Kwan JYY, Waddle M, Sonis S, Herst P, Alcorn S, Bonomo P, Wong C, Corbin K, Choi JI, Rembielak A, AlKhaifi M, Marta GN, Rades D, van den Hurk C, Wolf JR, Chan RJ, Schmeel LC, Lock M, Hijal T, Cao J, Kim H, Chow E. Barrier films or dressings for the prevention of acute radiation dermatitis in breast cancer: a systematic review and network meta-analysis. Breast Cancer Res Treat. 2024 Oct;207(3):477-496. doi: 10.1007/s10549-024-07435-2. Epub 2024 Aug 7.
- Background: PubMed 32949772Yee C, Lam E, Gallant F, Karam I, Czarnota G, Soliman H, Wong G, Drost L, Vesprini D, Rakovitch E, Wronski M, Leung E, Szumacher E, Carothers K, Pon K, Gonzales G, Easton L, Lewis D, Zhang L, Chow E. A Feasibility Study of Mepitel Film for the Prevention of Breast Radiation Dermatitis in a Canadian Center. Pract Radiat Oncol. 2021 Jan-Feb;11(1):e36-e45. doi: 10.1016/j.prro.2020.09.004. Epub 2020 Sep 17.
- Background: PubMed 28417508Fernandez-Castro M, Martin-Gil B, Pena-Garcia I, Lopez-Vallecillo M, Garcia-Puig ME. Effectiveness of semi-permeable dressings to treat radiation-induced skin reactions. A systematic review. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12685. Epub 2017 Apr 18.
- Background: PubMed 32587626Iacovelli NA, Torrente Y, Ciuffreda A, Guardamagna VA, Gentili M, Giacomelli L, Sacerdote P. Topical treatment of radiation-induced dermatitis: current issues and potential solutions. Drugs Context. 2020 Jun 12;9:2020-4-7. doi: 10.7573/dic.2020-4-7. eCollection 2020.
- Background: PubMed 37905662Tsai PC, Liu YC, Li TS, Hsu FT, Lee YH, Chiang IT, Chang Y, Lee CH. Clinical Effect of Moisturized Skin Care on Radiation Dermatitis of Head and Neck Cancer. In Vivo. 2023 Nov-Dec;37(6):2776-2785. doi: 10.21873/invivo.13389.
- Background: PubMed 22350025Zenda S, Ishi S, Kawashima M, Arahira S, Tahara M, Hayashi R, Kishimoto S, Ichihashi T. A Dermatitis Control Program (DeCoP) for head and neck cancer patients receiving radiotherapy: a prospective phase II study. Int J Clin Oncol. 2013 Apr;18(2):350-5. doi: 10.1007/s10147-012-0385-9. Epub 2012 Feb 15.
- Background: PubMed 25673153Zenda S, Ishi S, Akimoto T, Arahira S, Motegi A, Tahara M, Hayashi R, Asanuma C. DeCoP, a Dermatitis Control Program using a moderately absorbent surgical pad for head and neck cancer patients receiving radiotherapy: a retrospective analysis. Jpn J Clin Oncol. 2015 May;45(5):433-8. doi: 10.1093/jjco/hyv010. Epub 2015 Feb 11.
- BackgroundAgnihotri V, Kshirsagar AY. To assess the incidence of radiation dermatitis among the cancer patients receiving radiotherapy. Int J Nurs Med Invest. 2018;3(3):107-110.
- Individual participant dataSharing planned: Undecided
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Head and Neck Cancer, run by King Faisal Specialist Hospital & Research Center.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients developing Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≥2 dermatitis by completion of radiotherapy. (time frame: Day 7,14,21,28,35 of radiotherapy for all patients registered in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07357506, which also lists 11 linked publications.
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 22 Jan 2026.