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

Phase 3

Completed

• Conditions: Head and Neck Carcinoma; Radiation-Induced Dermatitis
• Interventions: Other: Placebo; Drug: Dakin's solution

• Registration Number: NCT02369835
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-24
• Study Start: 2015-05
• Primary Completion: 2018-07-18
• Study Completion: 2018-07-18
• Results First Submitted: 2019-07-31
• Results First Submitted QC: 2019-09-09
• Results First Posted: 2019-09-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (placebo)	Placebo	Participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment.
Arm I (modified Dakin's solution)	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.

Primary Outcome Measures

Name	Time	Method
Radiation Dermatitis	From first radiation treatment up to 10 weeks after completion of radiation treatment. Because much of the study data was not provided by the prior investigator to the current Responsible Party, it is not possible to be more precise than stated.	Participants were assessed for radiation dermatitis on the arms according to the Stanford Radiation Dermatitis Scoring System (SRDSS), at baseline and through their treatment course. The outcome is reported by treatment group as the number and proportion of participants that experience SRDSS Grade E or greater radiation dermatitis through 10 weeks after completion of radiation treatment, a number without dispersion.; SRDSS, by grade: * 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"

Secondary Outcome Measures

Name	Time	Method
Time to Grade E Radiation Dermatitis	up to 12 weeks (estimated)	Participants were assessed for radiation dermatitis on the arms according to the Stanford Radiation Dermatitis Scoring System (SRDSS), at baseline and through their treatment course. The time that SRDSS Grade E radiation dermatitis developed was noted. The outcome is reported by treatment group as the mean time to development of SRDSS Grade E radiation dermatitis, with standard deviation.; SRDSS, by grade: * 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."; Additional information describing this outcome is not available.
Pain Associated With Radiation Dermatitis	3 to 12 weeks after completion of radiation treatment	Quality of life was assessed as pain associated with radiation dermatitis. Assessments were baseline and through treatment follow-up 3 to 12 weeks after completion of radiation treatment. The assessment was to be conducted with a Modified Brief Pain Inventory (MBPI), a 13-question survey with responses ranging from 0 to 10, and an overall score of 0 to 130. A higher score indicates more pain and less quality of life. The outcome was to be reported by treatment group as the mean score with standard deviation.; Additional information describing this outcome is not available.

Trial Locations

Locations (2)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Stanford Cancer Center South Bay; 🇺🇸 San Jose, California, United States