Clinical trial · Interventional

Reducing Skin Side Effects in Patients Receiving Radiation on Tomotherapy

Mitigating Cutaneous Toxicity in Patients Undergoing TomoTherapy; A Randomized Controlled Trial of Skin-Protective Strategies

NCT07357506CI-TRIAL-00101444MCTPUTnot yet recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

* 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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Fragrance-Free Emollient (Glycerol-Based); A fragrance-free, glycerol-based emollient applied to the skin from day 1 of TomoTherapy.	Other	—	UNRESOLVED
Mepitel Film (Silicone-Based Semi-Permeable Barrier Film)	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Arm A: STDoC + fragrance-free emollient (glycerol-based) from day 1 + absorbent polyurethane foam dr
description
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).
interventionNames
1. Other: Fragrance-Free Emollient (Glycerol-Based); A fragrance-free, glycerol-based emollient applied to the skin from day 1 of TomoTherapy.
type
EXPERIMENTAL
label
Arm B: STDoC + silicone-based semi-permeable barrier film (Mepitel Film-equivalent) applied from day
description
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.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

Inclusion Criteria:

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

Exclusion Criteria:

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

References

Publications (11)

BACKGROUNDBjordal 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
BACKGROUNDAaronson 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
BACKGROUNDTayyib 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
BACKGROUNDWong 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
BACKGROUNDYee 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
BACKGROUNDFernandez-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.