NCT01487954

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiation Toxicity
• Recurrent Breast Cancer
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	alkaline water	Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
DIETARY_SUPPLEMENT	distilled water	Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.
RADIATION	external beam radiation therapy (EBRT)	Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-12-08
• Last updated: 2015-06-18
• Results posted: 2015-06-18

Locations

1 site across 1 country: United States