Reducing Skin Side Effects in Patients Receiving Radiation on Tomotherapy

NCT07357506 | Not Yet Recruiting DMC

• 1 other identifier: RAC#: 2251649
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Radiotherapy; Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  Day 7,14,21,28,35 during the course of radiotherapy

• Number of patients with maximum dermatitis grade during treatment.

  Day 7, 14, 21, 28, 35 of radiotherapy

• Number of patients with incidence of moist desquamation.

  Day 7, 14, 21, 28, 35 of radiotherapy treatment

• Number of patients with treatment interruptions >3 days due to skin toxicity.

  From beginning to end of radiotherapy treatment (Day 1 to Day 35)

• Patient-reported outcomes from EORTC QLQ-HN35 for each participant

  At baseline (Day 1), mid-treatment (Day 17) at end of radiotherapy treatment (Day 35).

Study Arms (2)

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).

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.

Device: Mepitel Film (Silicone-Based Semi-Permeable Barrier Film)

Interventions

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.

Arm B: STDoC + silicone-based semi-permeable barrier film (Mepitel Film-equivalent) applied from day

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.

Arm A: STDoC + fragrance-free emollient (glycerol-based) from day 1 + absorbent polyurethane foam dr

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 80 with newly diagnosed head and neck (H\&N) carcinoma (confirmed by pathology)
• Must be receiving radiotherapy using Tomotherapy

You may not qualify if:

• Prior H\&N radiotherapy
• pre-existing skin disease
• allergy to study products.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Related Publications (11)

• 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.

  PMID: 10071296 BACKGROUND

• Aaronson 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.

  PMID: 8433390 BACKGROUND

• Tayyib 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.

  PMID: 37601988 BACKGROUND

• Wong 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.

  PMID: 39112742 BACKGROUND

• Yee 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.

  PMID: 32949772 BACKGROUND

• Fernandez-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.

  PMID: 28417508 BACKGROUND

• Iacovelli 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.

  PMID: 32587626 BACKGROUND

• Tsai 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.

  PMID: 37905662 BACKGROUND

• Zenda 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.

  PMID: 22350025 BACKGROUND

• Zenda 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.

  PMID: 25673153 BACKGROUND

• Agnihotri 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.

  BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Dermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 22, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01