Spots Global Cancer Trial Database for Alkaline Water in Reducing Skin Toxicity in Women With Breast Cancer Undergoing Radiation Therapy

Study Description

Brief Summary: 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.

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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