Reducing Skin Side Effects in Patients Receiving Radiation on Tomotherapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKing Faisal Specialist Hospital & Research Center

About this trial

* 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 to 80 with newly diagnosed head and neck (H&N) carcinoma (confirmed by pathology)

Must be receiving radiotherapy using Tomotherapy

Disqualifiers

Prior H&N radiotherapy

pre-existing skin disease

allergy to study products.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fragrance-Free Emollient (Glycerol-Based); A fragrance-free, glycerol-based emollient applied to the skin from day 1 of TomoTherapy.

    Other intervention

    A foam dressing applied to areas of Grade ≥2 radiation dermatitis for skin protection during TomoTherapy. Part of Arm A.

  • 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.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Arm A: STDoC + fragrance-free emollient (glycerol-based) from day 1 + absorbent polyurethane foam drActive comparator 1 intervention
Group B: Arm B: STDoC + silicone-based semi-permeable barrier film (Mepitel Film-equivalent) applied from dayExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
Day 7,14,21,28,35 of radiotherapy for all patients registered in the study

Secondary outcomes

1

-Number of days to start of Grade ≥2 dermatitis between arms.

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)

Time frame
Day 7,14,21,28,35 during the course of radiotherapy
2

Number of patients with maximum dermatitis grade during treatment.

Number of patients with maximum dermatitis grade during treatment.

Time frame
Day 7, 14, 21, 28, 35 of radiotherapy
3

Number of patients with incidence of moist desquamation.

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)

Time frame
Day 7, 14, 21, 28, 35 of radiotherapy treatment
4

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

Any interruptions in radiotherapy treatment \>3 days due to skin toxicity

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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