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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Carcinoma; Radiation-Induced Dermatitis
• Intervention / Treatment: Other: Placebo; Drug: Dakin's solution

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 Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95124
      • Stanford Cancer Center South Bay
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Dakin's solution; Apply modified Dakin's solution (0.005 to 0.01%) topically; Other Names: Sodium hypochlorite in aqueous solution; Dakin's fluid; Liquid bleach
Placebo Comparator: 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.	Other: Placebo; Applied topically; Other Names: PLCB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Beth Beadle, Stanford University Hospitals and Clinics

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): July 18, 2018
• Study Completion (Actual): July 18, 2018

Study Registration Dates

• First Submitted: February 17, 2015
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (Estimated): February 24, 2015

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Radiation Injuries; Head and Neck Neoplasms; Dermatitis; Radiodermatitis; Anti-Infective Agents; Disinfectants; Pharmaceutical Solutions; Sodium Hypochlorite; Eusol
• Other Study ID Numbers: IRB-32439 (Other Identifier: Stanford IRB); NCI-2015-00176 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); ENT0042 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No