Trial Outcomes & Findings for Dakin's Solution in Preventing Radiation Dermatitis in Patients With Breast Cancer Undergoing Radiation Therapy (NCT NCT02203565)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Baseline to up to 6 weeks after completion of therapy

Results posted on

2017-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	Supportive Care (Dakin's Solution, Radiation Therapy) 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
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supportive Care (Dakin's Solution, Radiation Therapy) n=20 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to up to 6 weeks after completion of therapy

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

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

Outcome measures

Outcome measures
Measure	Supportive Care (Dakin's Solution, Radiation Therapy) n=14 Participants 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
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	6 Participants

Adverse Events

Supportive Care (Dakin's Solution, Radiation Therapy)

Serious events: 3 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Supportive Care (Dakin's Solution, Radiation Therapy) n=20 participants at risk 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
Skin and subcutaneous tissue disorders Dermatitis radiation	15.0% 3/20 • Number of events 3 • Adverse event data was collected throughout radiation treatment, approximately 5 weeks, for each patients. For the study overall adverse events were monitored for various patients over the course of 1 year when the study was open to accrual.

Other adverse events

Other adverse events
Measure	Supportive Care (Dakin's Solution, Radiation Therapy) n=20 participants at risk 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
Skin and subcutaneous tissue disorders Radiation Dermatitis	100.0% 20/20 • Number of events 20 • Adverse event data was collected throughout radiation treatment, approximately 5 weeks, for each patients. For the study overall adverse events were monitored for various patients over the course of 1 year when the study was open to accrual.

Additional Information

Dr. Kathleen Horst

Stanford University School of Medicine

Phone: 6507256009

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place