Evaluation of StratXRT and RadiaPlexRx Gel for the Prevention of Radiation Dermatitis in Head and Neck Cancer Patients

Status: administratively complete

This phase II trial compares the effectiveness of skin protection agents, silicone-based film forming topical gel (StrataXRT) and sodium hyaluronate topical hydrogel (RadiaPlexRx Gel) in preventing radiation dermatitis during radiation therapy in patients with head and neck cancer. Radiation dermatitis is a common side effect of radiation therapy that causes inflammation of the skin, that may make it sore, peel, itch or turn red. StrataXRT is a gel that creates a protective layer that maintains skin integrity and may promote a moist wound healing environment leading to increased wound healing and skin recovery. RadiaPlexRx Gel is a gel formulation that adheres to injured tissues and provides protection from further chemical or mechanical irritation that may improve wound repair. Applying StrataXRT or RadiaPlexRx Gel to the unprotected areas of the skin may reduce radiation dermatitis severity in patients with head and neck cancer undergoing radiation therapy.

Inclusion Criteria

Age >= 18 years
Undergoing external beam radiotherapy for head/neck cancer at Mayo Clinic Rochester campus. Note: patients undergoing concurrent chemotherapy are eligible.
Able to provide informed written consent
Willing to consent for photography of radiation field
Receiving a dose >= 45 Gy and 20 fractions to both the area being treated and the area being used for comparison

Exclusion Criteria

Patients with active rash, pre-existing dermatitis, lupus, tattoos, scleroderma or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion
Patients with known allergic and other systemic skin diseases even if not directly affecting irradiated fields
Any medical condition that in the opinion of the investigator should exclude him/her from participating in the study
Enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit
The skin area affected by radiation requires treatment with a concomitant medication or product (if applicable)

PRIMARY OBJECTIVE:

I. To compare radiation dermatitis severity in irradiated skin protected by an agent versus uncovered skin (internal control) based on photographs.

SECONDARY OBJECTIVE:

I. Describe patient reported outcomes with use of the agent.

OUTLINE: Patients are assigned to 1 of 2 groups.

Group 1: Patients receive instruction on proper application then apply StrataXRT topically to the directed area of skin at the onset of radiation therapy and at least once daily (QD) until skin symptoms subside or as needed. Patients also undergo digital photography of skin throughout radiation therapy.

Group 2: Patients receive instruction on proper application then apply RadiaPlexRx Gel topically to the directed area of skin at the onset of radiation therapy before and after treatments and two other times daily (BID) or as needed. Patients also undergo digital photography of skin throughout radiation therapy.

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Evaluation of StratXRT and RadiaPlexRx Gel for the Prevention of Radiation Dermatitis in Head and Neck Cancer Patients

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