A Phase 2 interventional study of Dakin's solution and radiation therapy in Breast Cancer and Skin Reactions Secondary to Radiation Therapy, sponsored by Stanford University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-26.
Sponsored by Stanford University · Phase 2, Interventional, and Supportive care
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 20 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.
Drug: Dakin's solution · Radiation: radiation therapy · Other: questionnaire administration · Other: laboratory biomarker analysis
Applied topically
Also known as: aqueous solution of sodium hypochlorite, Dakin's fluid
Undergo radiation therapy
Also known as: irradiation, radiotherapy, therapy, radiation
Ancillary studies
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
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
| Milestone | Supportive Care (Dakin's Solution, Radiation Therapy) |
|---|---|
| Started | 20 |
| Completed | 19 |
| Not completed | 1 |
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
| 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 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Supportive Care (Dakin's Solution, Radiation Therapy) | 0/20 (0%) | 3/20 (15%) | 20/20 (100%) |
| Event | Supportive Care (Dakin's Solution, Radiation Therapy) |
|---|---|
| Dermatitis radiationSkin and subcutaneous tissue disorders | 3/20 |
| Event | Supportive Care (Dakin's Solution, Radiation Therapy) |
|---|---|
| Radiation DermatitisSkin and subcutaneous tissue disorders | 20/20 |
| Age, Categorical(Participants) | Supportive Care (Dakin's Solution, Radiation Therapy) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 17 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | Supportive Care (Dakin's Solution, Radiation Therapy) |
|---|---|
| Female | 20 |
| Male | 0 |
| Region of Enrollment(Participants) | Supportive Care (Dakin's Solution, Radiation Therapy) |
|---|---|
| United States | 20 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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