- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01487954
Alkaline Water in Reducing Skin Toxicity in Women With Breast Cancer Undergoing Radiation Therapy
Alkaline Water Consumption to Reduce Skin Radiation Toxicity in Women With Breast Cancer
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
I. The goal of this two-phase study is to assess the rate of grade 2 or higher radiation-related skin toxicity in adult patients with breast malignancies after administration of alkaline (pH 9.0) or distilled (pH 7.0) water consumed immediately prior to and after daily radiation treatments.
OUTLINE:
FEASIBILITY PHASE: Patients undergo external beam radiation therapy once daily (QD), 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
INTERVENTION PHASE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
ARM II: Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 month.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ohio
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Westlake, Ohio, United States, 44145
- University Hospitals-Westlake
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed stage 0-IV breast cancer and have a treatment plan consisting of 62Gy (31 fractions) of total breast radiation therapy to be eligible; patients are eligible if they have received any number of prior chemotherapies; patients having received chemotherapy prior to radiation will be stratified among randomization groups during the second phase of this study
- Life expectancy of greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients receiving any investigational chemotherapeutic agents during planned radiation or any prior breast or chest wall radiation treatments are excluded
- Patients receiving concurrent chemotherapy are excluded because of an increased relative risk of skin toxicity; patients taking daily proton-pump inhibitor or H2-blocker antacid medications are excluded because of predicted interference of alkaline water consumption and stomach pH; herceptin for the purposes of this clinical trial would be considered a chemotherapy, and as such, patients receiving herceptin chemotherapy during radiation would not be eligible for participation in this protocol
- Patients with a history of any prior malignancy except non-melanoma skin cancer or carcinoma in-situ of the cervix not in remission for twelve months are excluded; patients with known brain metastases are excluded from this clinical trial because of their overall poor prognosis
- Pregnancy excludes female patients from this study because radiation is potentially teratogenic and abortifacient; screening beta-hcg levels and clinically-indicated diagnostic tests will be used to determine eligibility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I: alkaline water
Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.
Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
|
Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.
|
Active Comparator: Arm II: distilled water
Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy
|
Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.
Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time Frame: at 1 month after treatment
|
Information will include the type, severity, time of onset and resolution of its onset, and its probable association with the study regimen.
Frequency tables will be constructed to summarize observed incidents by severity and type of toxicity during weekly radiation treatment and 1 month after radiation treatment.
Observed toxicity differences among the treatment arms may be reported in frequency tables.
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at 1 month after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Urine pH
Time Frame: at baseline and at week 5 (day 33)
|
A paired sample t-test (a=0.05)
assessing change in urine pH between before treatment day 0 and after radiation and alkaline water treatment day 33.
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at baseline and at week 5 (day 33)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Charles Kunos, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE2109
- NCI-2010-01233 (Other Identifier: NCI/CTRP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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