Study of Topical Superoxide Dismutase to Treat Radiation Induced Fibrosis (Sodermix)

Sanford Health

Status: Completed

Conditions: Radiation Induced Fibrosis to the Head and Neck

Treatments: Drug: Placebo; Drug: Topical Sodermix Dismutase in the form of Sodermix (SOD)

Study type: Interventional

Funder types: Other

Identifiers

NCT01771991

SOD 2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• must have evidence of neck fibrosis
• previous radiation treatment to the neck for cancer
• age greater than or equal to 18 years
• life expectancy of greater than 12 weeks
• ability to understand the purpose of the study and the willingness to sign a written informed consent document.

Exclusion criteria

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to SOD or Cetaphil cram.
• any psychological, familial, sociological or geographical conditions that do not permit medical follow-up and compliance with the study protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups, including a placebo group

Topical Sodermix Dismutase

Experimental group

Description:

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.

Treatment:

Drug: Topical Sodermix Dismutase in the form of Sodermix (SOD)

Placebo group

Placebo Comparator group

Description:

Cetaphil cream

Treatment:

Drug: Placebo