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

January 21, 2026 updated by: Zaheeda Mulla, King Faisal Specialist Hospital & Research Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A: STDoC + fragrance-free emollient (glycerol-based) from day 1 + absorbent polyurethane foam dr
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.
A foam dressing applied to areas of Grade ≥2 radiation dermatitis for skin protection during TomoTherapy. Part of Arm A.
Experimental: Arm B: STDoC + silicone-based semi-permeable barrier film (Mepitel Film-equivalent) applied from day
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 7,14,21,28,35 of radiotherapy for all patients registered in the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
-Number of days to start of Grade ≥2 dermatitis between arms.
Time Frame: Day 7,14,21,28,35 during the course 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 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)
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 maximum dermatitis grade during treatment.
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
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)
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)
Any interruptions in radiotherapy treatment >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
Time Frame: At baseline (Day 1), mid-treatment (Day 17) at end of radiotherapy treatment (Day 35).
  • 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.
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).
• 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.
At baseline (Day 1), mid-treatment (Day 17) at end of radiotherapy treatment (Day 35).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Faisal Specialist Hospital & Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAC#: 2251649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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