Skin and Connective Tissue Diseases

All Conditions

Neoplasms

Wounds and Injuries

Dermatitis

Carcinoma

Head and Neck Neoplasms

Radiodermatitis

Skin Diseases

Radiation Injuries

Anti-Infective Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Sodium Hypochlorite

Eusol

Disinfectants

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.

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

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

Dakin's solution

Placebo

Beth Beadle

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.

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.

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

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"

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.

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.

National Cancer Institute (NCI)

Stanford University

Associate Professor of Radiation Oncology

Reported adverse events represent the entire set of adverse events as available to the current investigator and Responsible Party. There are no additional events available to report, and there never will be.

Arm I (Modified Dakin's Solution)

Arm II (Placebo)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Baseline dermatitis

Not all participants completed radiation treatment, and are not included in the outcome.

Radiation Dermatitis

Data for time to Grade E radiation dermatitis was not provided by the prior investigator to the current Responsible Party. On this basis, data is not available, and will never be available.

Time to Grade E Radiation Dermatitis

Data for pain associated with radiation dermatitis was not provided by the prior investigator to the current Responsible Party. On this basis, data is not available, and will never be available.

Pain Associated With Radiation Dermatitis

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.

radiation therapy

questionnaire administration

laboratory biomarker analysis

Kathleen Horst

This pilot clinical trial studies Dakin's solution in preventing radiation dermatitis in patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a skin condition in which the affected skin becomes painful, red, itchy, and blistered. Dakin's solution may help reduce dermatitis caused by radiation therapy.

PRIMARY OBJECTIVES:

I. To determine the percent change in women who experience grade 3 or 4 radiation dermatitis as defined by the Stanford Radiation Dermatitis Scoring System during radiation treatment for breast cancer compared to historical experience using standard skin care.

SECONDARY OBJECTIVES:

I. To assess the feasibility of daily application of the hypochlorite solution (Dakin's solution), and to assess levels of pain during radiotherapy treatment.

OUTLINE:

Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.

After completion of study treatment, patients are followed up at 4-6 weeks.

Dakin's Solution in Preventing Radiation Dermatitis in Patients With Breast Cancer Undergoing Radiation Therapy

Pilot Study to Investigate the Impact of Hypochlorite in the Prevention of Radiation Dermatitis

Stanford Radiation Dermatitis Scoring System:

Grade Clinical finding

0 No skin change

1 Faint, barely detectable erythema 2 Follicular rash, hyperpigmentation, evolving erythema 3 Dry desquamation, brisk erythema 4 Moist desquamation 5 Bleeding, ulceration, and/or infection

Assistant Professor of Radiation Oncology

Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.

Dakin's solution: Applied topically

radiation therapy: Undergo radiation therapy

questionnaire administration: Ancillary studies

laboratory biomarker analysis: Optional correlative studies

Supportive Care (Dakin's Solution, Radiation Therapy)

Dr. Kathleen Horst

Patients with complete data for analysis. While 20 patients were enrolled in the study, only 14 had data available for analysis.

Percent of Women Who Develop Grade 3 or 4 Radiation Dermatitis (as Defined by the Stanford Radiation Dermatitis Scoring System) During a Course of Radiation Therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy	NCT02369835	Head and Neck C... Radiation-Induc...	Dakin's solutio... Placebo	18 Years -	Stanford University
Dakin's Solution in Preventing Radiation Dermatitis in Patients With Breast Cancer Undergoing Radiation Therapy	NCT02203565	Breast Cancer Skin Reactions ...	Dakin's solutio... radiation thera... questionnaire a... laboratory biom...	18 Years -	Stanford University
Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy	NCT02369835	Head and Neck C... Radiation-Induc...	Dakin's solutio... Placebo	18 Years -	Stanford University

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