Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy

NCT ID: NCT02369835

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-07-18

Brief Summary

This randomized phase 3 trial studies how well modified Dakin's solution works in reducing radiation-induced dermatitis, a common skin reaction to radiation therapy, in patients with head and neck cancer undergoing radiation therapy. Modified Dakin's solution may reduce inflammation in the body, which may prevent or reduce dermatitis after radiation therapy.

Radiation therapy in this study is regulatory medical care based on the patient's needs and the radiation oncologist's judgment. It is not possible nor necessary to explicitly define the dose or duration of treatment.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the proportion of patients who develop grade 3 radiation dermatitis (as defined by the Stanford Radiation Dermatitis Scoring System) as an adverse effect of radiation therapy or chemoradiation therapy for a head and neck cancer when initiating the use of prophylactic hypochlorite (HOCl) (modified Dakin's solution) at the start of therapy (experimental arm) compared to placebo (control arm).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (EXPERIMENTAL): Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.

ARM II (CONTROL): Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.

At the time that Stanford Radiation Dermatitis Scoring System (SRDSS) Grade E radiation dermatitis develops, the participant will transition to standard management for radiation dermatitis. SRDSS, by grade, is as follows.

• A. No skin change
• B. Faint, barely detectable erythema
• C. Follicular rash, hyperpigmentation, evolving erythema
• D. Dry desquamation, brisk erythema
• E. Moist desquamation
• F. Bleeding, ulceration, and/or infection

SRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, "Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion."

After completion of study, patients are followed up at 6 to 10 weeks.

Conditions

Head and Neck Carcinoma; Radiation-Induced Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Arm I (modified Dakin's solution)

Participants apply modified Dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.

Group Type: EXPERIMENTAL

Dakin's solution

Intervention Type: DRUG

Apply modified Dakin's solution (0.005 to 0.01%) topically

Arm II (placebo)

Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Applied topically

Interventions

Dakin's solution

Apply modified Dakin's solution (0.005 to 0.01%) topically

Intervention Type: DRUG

Placebo

Applied topically

Intervention Type: OTHER

Other Intervention Names

Sodium hypochlorite in aqueous solution; Dakin's fluid; Liquid bleach; PLCB

Eligibility Criteria

Inclusion Criteria

• Head and neck cancer who plan to undergo radiation therapy to the head and neck region
• At least 18 years of age
• Able to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Prior radiation therapy to the head and neck region or prior chemotherapy for head and neck cancer (induction chemotherapy NOT excluded)
• The physician-approved radiation treatment plan indicates a maximum prescription dose of less than 45 Gy
• Scleroderma or discoid lupus

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Beth Beadle

Associate Professor of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beth Beadle

Role: PRINCIPAL_INVESTIGATOR

Stanford University Hospitals and Clinics

Locations

Stanford Cancer Center South Bay

San Jose, California, United States

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2015-00176

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB-32439

Identifier Type: OTHER

Identifier Source: secondary_id

ENT0042

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-32439

Identifier Type: -

Identifier Source: org_study_id