Stage IV Breast Cancer Clinical Trial
Official title:
Alkaline Water Consumption to Reduce Skin Radiation Toxicity in Women With Breast Cancer
This phase II trial is studying how well alkaline water works in reducing skin toxicity in women with breast cancer undergoing radiation therapy. Alkaline water may reduce radiation therapy-related skin toxicity in patients with breast cancer.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
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