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


Phase 2
18 Years
N/A
Not Enrolling
Female
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Outcome Measure:

Acute and grade 2 or higher radiation-related skin toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

Outcome Description:

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.

Outcome Time Frame:

at 1 month after treatment

Safety Issue:

Yes

Principal Investigator

Charles Kunos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Institutional Review Board

Study ID:

CASE2109

NCT ID:

NCT01487954

Start Date:

May 2010

Completion Date:

November 2012

Related Keywords:

  • 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
  • skin reactions secondary to radiation therapy
  • Breast Neoplasms
  • Radiation Injuries

Name

Location
University Hospitals-Westlake Westlake, Ohio  44145