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Reducing Skin Side Effects in Patients Receiving Radiation on Tomotherapy

NCT07357506 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-01-22

No results posted yet for this study

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

Interventions

OTHER

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.

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.

Sponsors & Collaborators

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2028-01-31
Completion
2028-01-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07357506 on ClinicalTrials.gov