Alkaline Water Consumption to Reduce Skin Radiation Toxicity in Women With Breast Cancer
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.
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
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 month.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Acute and grade 2 or higher radiation-related skin toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
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.
at 1 month after treatment
Charles Kunos, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Institutional Review Board
|University Hospitals-Westlake||Westlake, Ohio 44145|