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

Head and Neck Carcinoma Clinical Trial

Official title:

A Randomized Study of Topical Dilute Hypochlorite (Modified Dakin's Solution) Treatment for the Prevention of Radiation Dermatitis in Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369835
• Other study ID #: IRB-32439
• Secondary ID: NCI-2015-00176IR
• Status: Completed
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: July 18, 2018

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 18, 2018
• Est. primary completion date: July 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Head and Neck Carcinoma
• Head and Neck Neoplasms
• Radiation-Induced Dermatitis
• Radiodermatitis

Intervention

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

Other:
• Placebo
Applied topically

Locations

Country	Name	City	State
United States	Stanford Cancer Center South Bay	San Jose	California
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation Dermatitis	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"	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.
Secondary	Time to Grade E Radiation Dermatitis	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.	up to 12 weeks (estimated)
Secondary	Pain Associated With Radiation Dermatitis	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.	3 to 12 weeks after completion of radiation treatment