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

NCT ID: NCT01487954

Last Updated: 2015-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-11-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Arm I: alkaline water

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.

Group Type: EXPERIMENTAL

alkaline water

Intervention Type: DIETARY_SUPPLEMENT

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

external beam radiation therapy (EBRT)

Intervention Type: RADIATION

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

Arm II: distilled 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

Group Type: ACTIVE_COMPARATOR

distilled water

Intervention Type: DIETARY_SUPPLEMENT

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

external beam radiation therapy (EBRT)

Intervention Type: RADIATION

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

Interventions

alkaline water

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

Intervention Type: DIETARY_SUPPLEMENT

distilled water

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

Intervention Type: DIETARY_SUPPLEMENT

external beam radiation therapy (EBRT)

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Patients must have histologically or cytologically confirmed stage 0-IV breast cancer and have a treatment plan consisting of 62Gy (31 fractions) of total breast radiation therapy to be eligible; patients are eligible if they have received any number of prior chemotherapies; patients having received chemotherapy prior to radiation will be stratified among randomization groups during the second phase of this study
• Life expectancy of greater than 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Patients receiving any investigational chemotherapeutic agents during planned radiation or any prior breast or chest wall radiation treatments are excluded
• Patients receiving concurrent chemotherapy are excluded because of an increased relative risk of skin toxicity; patients taking daily proton-pump inhibitor or H2-blocker antacid medications are excluded because of predicted interference of alkaline water consumption and stomach pH; herceptin for the purposes of this clinical trial would be considered a chemotherapy, and as such, patients receiving herceptin chemotherapy during radiation would not be eligible for participation in this protocol
• Patients with a history of any prior malignancy except non-melanoma skin cancer or carcinoma in-situ of the cervix not in remission for twelve months are excluded; patients with known brain metastases are excluded from this clinical trial because of their overall poor prognosis
• Pregnancy excludes female patients from this study because radiation is potentially teratogenic and abortifacient; screening beta-hcg levels and clinically-indicated diagnostic tests will be used to determine eligibility

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Kunos, MD

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

University Hospitals-Westlake

Westlake, Ohio, United States

Countries

United States

Other Identifiers

NCI-2010-01233

Identifier Type: OTHER

Identifier Source: secondary_id

CASE2109

Identifier Type: -

Identifier Source: org_study_id