Clinical Trial: Alkaline Water in Reducing Skin Toxicity in Women With Breast Cancer Undergoing Radiation Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Alkaline Water Consumption to Reduce Skin Radiation Toxicity in Women With Breast Cancer

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 Summary:

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.


Sponsor: Case Comprehensive Cancer Center

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Case Comprehensive Cancer Center

Dates:
Date Received: December 5, 2011
Date Started: May 2010
Date Completion:
Last Updated: June 1, 2015
Last Verified: June 2015