NCT05073172

StrataXRT for the Prevention and Treatment of Radiation Dermatitis in Breast Cancer or Head and Neck Cancer Patients

A Randomized Intra-Patient Controlled Study of StrataXRT ® Versus Current Practice to Prevent and Treat Radiation Dermatitis

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies the effect of StrataXRT in preventing and treating radiation dermatitis in breast cancer or head and neck cancer patients. Radiotherapy is often associated with multiple side effects. These side effects can cause patient injury and make it difficult to complete treatment. For example, radiation dermatitis or skin damage may result in severe skin peeling and skin irritation. Depending on the location of radiation, the skin damage can cause problems and be tough to heal. This trial aims to see whether StrataXRT may help to prevent dermatitis after radiation therapy.

Detailed description

PRIMARY OBJECTIVE: I. Compare efficacy of silicone-based film forming topical gel (StrataXRT) versus (vs.) standard of care skin maintenance. SECONDARY OBJECTIVES: I. Evaluate overall effectiveness of StrataXRT. II. Evaluate post-radiation therapy (RT) recovery time for StrataXRT compared to standard of care. EXPLORATORY OBJECTIVES: I. To assess patient reported outcomes. II. Evaluate cost of StrataXRT for management of radiation dermatitis compared to standard of care skin maintenance. III. Evaluate the reduction in RT interruption/extension of overall duration of receiving RT based on the reduced skin toxicity. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients apply StrataXRT topically to the affected area once or twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =\< 1. ARM II: Patients receive standard of care including calendula and/or petrolatum-mineral oil-lanolin-ceresin ointment (Aquaphor) applied 2-6 times daily plus hydrogel or silver sulfadiazine (Silvadene) or topical corticosteroids applied twice daily starting from the first dose of radiation therapy until dermatitis has returned to grade =\< 1. After completion of study, patients are followed up at 6 days and 3 weeks post-RT.

Conditions

• Breast Carcinoma
• Head and Neck Carcinoma
• Radiation-Induced Dermatitis

Interventions

Type	Name	Description
DRUG	Calendula Ointment	Applied topically
OTHER	Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment	Applied topically
OTHER	Polyethylene Glycol Hydrogel	Applied topically
DRUG	Silicone-based Film Forming Topical Gel	Applied topically
DRUG	Silver Sulfadiazine	Applied topically
DRUG	Topical Hydrocortisone	Applied topically

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-31
• Completion: 2025-07-01
• First posted: 2021-10-11
• Last updated: 2024-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study