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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01551 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| IRB-29833 | |||
| BRS0039 | Other Identifier | OnCore | |
| P30CA124435 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (Dakin's solution, radiation therapy) | Experimental | Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dakin's solution | Drug | Applied topically |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to up to 6 weeks after completion of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Horst | Stanford University Hospitals and Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| radiation therapy | Radiation | Undergo radiation therapy |
|
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| questionnaire administration | Other | Ancillary studies |
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| laboratory biomarker analysis | Other | Optional correlative studies |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Patients with complete data for analysis. While 20 patients were enrolled in the study, only 14 had data available for analysis. | Posted | Count of Participants | Participants | Baseline to up to 6 weeks after completion of therapy |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 20 | 3 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis radiation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Radiation Dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Patients were evaluated for Radiation Dermatitis of all grades (1-4) as defined by CTCAE guidlines. Radiation dermatitis is an expected side effect of radiation therapy and not associated with or an expected reaction to the Dakin's solution. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen Horst | Stanford University School of Medicine | 6507256009 | kateh@stanford.edu |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D012973 | Sodium Hypochlorite |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D006997 | Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017670 | Sodium Compounds |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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