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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 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 drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.

alkaline water

Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.

distilled water

Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.

external beam radiation therapy (EBRT)

Charles Kunos, MD

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.

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

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.

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.

National Cancer Institute (NCI)

Case Comprehensive Cancer Center

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.

alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.

external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.

Arm I: Alkaline 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

distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.

external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.

Arm II: Distilled Water

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Charles A. Kunos, MD, PhD

Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

pH at baseline

pH at day 33 of treatment

Only the first ten patients in the alkaline water group, who took part in the safety lead-in portion of the study were analyzed for urine pH

Spots Global Cancer Trial Database for alkaline water