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

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

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.
  • Mepitel Film (Silicone-Based Semi-Permeable Barrier Film)

Treatment groups

104 Participants
are divided into 2 treatment groups

Locations

This trial has no locations