Breast Cancer, Skin Reactions Secondary to Radiation Therapy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGDakin's solution
Applied topically
RADIATIONradiation therapy
Undergo radiation therapy
OTHERquestionnaire administration
Ancillary studies
OTHERlaboratory biomarker analysis
Optional correlative studies
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with breast cancer who plan to undergo radiation therapy to the breast or chest wall * Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Women with scleroderma or discoid lupus * Women with inflammatory breast cancer as evidenced by clinical assessment * Women with breast cancer involving the skin * Women who have undergone prior radiotherapy to the chest wall and/or breast
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline to up to 6 weeks after completion of therapy | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Supportive Care (Dakin's Solution, Radiation Therapy) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 3 / 20 |
Outcome results
Primary
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
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
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care (Dakin's Solution, Radiation Therapy) | 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 |