Conditions: Radiation Induced Fibrosis to the Head and Neck
Keywords: fibrosis radiation neck cancer Sodermix
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 74
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if topical superoxide dismutase is an effective treatment of radiation related neck fibrosis, and to determine the quality of life impact from radiation related fibrosis in the head and neck cancer patients at Sanford Health.

Detailed description:
The primary goal of this study is to evaluate the effect of topical Superoxide Dismutase (SOD) on the radiation induced fibrosis in head and neck cancer patients. A prospective, blinded, two group control design will be used with pretest and post test quality of life as well as objective fibrosis assessment. Patients will be randomized to alternatively receive topical SOD or placebo as instructed on twice daily use for 3 months. Pre and post treatment quality of life surveys and objective assessment will determine if the topical SOD improves neck fibrosis/function and global quality of life.

This study will increase clinical trial awareness and participation while potentially improving the long term functional outcomes of head and neck cancer patients.

Arms:
arm 1: Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to applying Topical Sodermix Dismutase in the form of Sodermix(SOD) to the area of neck skin fibrosis twice a day for 12 weeks. arm 2: Cetaphil cream

Interventions: intervention 1: Topical Sodermix Dismutase in the form of Sodermix (SOD) intervention 2: Placebo
Intervention descriptions: intervention 1: Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area. intervention 2: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.

Protocol document: