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
Conditions
Keywords
skin reactions secondary to radiation therapy
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.
Interventions
DIETARY_SUPPLEMENTalkaline water
Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
DIETARY_SUPPLEMENTdistilled water
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.
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | at 1 month after treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Urine pH | at baseline and at week 5 (day 33) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. | 29 |
| 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
distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.
external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. | 16 |
| Total | 45 |
Baseline characteristics
| Characteristic | Arm I: Alkaline Water | Total | Arm II: Distilled Water |
|---|---|---|---|
| Age, Continuous | 57 years | 57 years | 53 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 44 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 43 Participants | 16 Participants |
| Region of Enrollment United States | 29 participants | 45 participants | 16 participants |
| Sex: Female, Male Female | 29 Participants | 45 Participants | 16 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 29 | 13 / 16 |
| serious Total, serious adverse events | 1 / 29 | 1 / 16 |
Outcome results
Primary
Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
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.
Time frame: at 1 month after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I: Alkaline Water | Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | 38 percentage of participants |
| Arm II: Distilled Water | Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | 38 percentage of participants |
Secondary
Change in Urine pH
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.
Time frame: at baseline and at week 5 (day 33)
Population: Only the first ten patients in the alkaline water group, who took part in the safety lead-in portion of the study were analyzed for urine pH
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Alkaline Water | Change in Urine pH | pH at baseline | 5.6 units on pH scale | Standard Deviation 0.7 |
| Arm I: Alkaline Water | Change in Urine pH | pH at day 33 of treatment | 6.1 units on pH scale | Standard Deviation 1 |