Alkaline Water in Reducing Skin Toxicity in Women With Breast Cancer Undergoing Radiation Therapy
Condition: 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
MeSH terms: Breast Neoplasms
Intervention: alkaline water; distilled water; external beam radiation therapy (EBRT)
Intervention description: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.; Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.; Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 45.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: skin reactions secondary to radiation therapy

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.
    

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