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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01487954
First received: December 5, 2011
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
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
Dietary Supplement: alkaline water
Dietary Supplement: distilled water
Radiation: external beam radiation therapy (EBRT)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: Alkaline Water Consumption to Reduce Skin Radiation Toxicity in Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change in urine pH [ Time Frame: at baseline and at week 5 (day 33) ] [ Designated as safety issue: No ]
    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.


Enrollment: 45
Study Start Date: May 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Dietary Supplement: alkaline water
Patients drink 8 ounces of alkaline 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.
Active Comparator: 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
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487954

Locations
United States, Ohio
University Hospitals-Westlake
Westlake, Ohio, United States, 44145
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Charles Kunos, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01487954     History of Changes
Other Study ID Numbers: CASE2109, NCI-2010-01233
Study First Received: December 5, 2011
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Case Comprehensive Cancer Center:
skin reactions secondary to radiation therapy

Additional relevant MeSH terms:
Breast Neoplasms
Radiation Injuries
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 19, 2014