Reducing Skin Side Effects in Patients Receiving Radiation on Tomotherapy (MCTPUT)

King Faisal Specialist Hospital & Research Center

Status: Not yet enrolling

Conditions: Head and Neck Cancer

Treatments: Device: Mepitel Film (Silicone-Based Semi-Permeable Barrier Film); Other: Fragrance-Free Emollient (Glycerol-Based); A fragrance-free, glycerol-based emollient applied to the skin from day 1 of TomoTherapy.

Study type: Interventional

Funder types: Other

Identifiers

NCT07357506

RAC#: 2251649

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

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

Active Comparator group

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).

Treatment:

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 group

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.

Treatment:

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