Phase 2
N=45
Alkaline Water in Reducing Skin Toxicity in Women With Breast Cancer Undergoing Radiation Therapy
Radiation Toxicity · Recurrent Breast Cancer · Stage I Breast Cancer · Stage II Breast Cancer · Stage IIIA Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01487954 ↗Enrolled (actual)
45
Serious AEs
4.4%
Results posted
Jun 2015
Primary outcome: Primary: Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 — 38; 38 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- alkaline water (Dietary_supplement); distilled water (Dietary_supplement); external beam radiation therapy (EBRT) (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 |
38; 38 | — |
| SECONDARY Change in Urine pH |
5.6; 6.1 | — |
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 = = 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
Data sourced from ClinicalTrials.gov (NCT01487954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.