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

• Sponsor: Case Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01487954
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 45
• Location: 1
• Arms: 2
• Duration (Months): 30.1
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

Detailed Description

OBJECTIVES:

1. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Supportive Care
• Official Title: Alkaline Water Consumption to Reduce Skin Radiation Toxicity in Women With Breast Cancer
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals-Westlake	Westlake	Ohio	United States	44145

Sponsors and Collaborators

• Case Comprehensive Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Charles Kunos, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT01487954
• Other Study ID Numbers: CASE2109; NCI-2010-01233
• First Posted: Dec 8, 2011
• Last Update Posted: Jun 18, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by Case Comprehensive Cancer Center: skin reactions secondary to radiation therapy
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Arm/Group Title	Arm I: Alkaline Water	Arm II: Distilled Water
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	29	16
Safety lead-in	10	0
COMPLETED	29	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arm I: Alkaline Water	Arm II: Distilled Water	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	29	16	45
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	57	53	57
Sex: Female, Male (Count of Participants)
Female	29 100%	16 100%	45 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3.4%	0 0%	1 2.2%
Not Hispanic or Latino	28 96.6%	16 100%	44 97.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 3.4%	0 0%	1 2.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 3.4%	0 0%	1 2.2%
White	27 93.1%	16 100%	43 95.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	29 100%	16 100%	45 100%

Outcome Measures

1. Primary Outcome

Title	Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
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.
Time Frame	at 1 month after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I: Alkaline Water	Arm II: Distilled Water
Arm/Group Description	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.	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.
Measure Participants	29	16
Number [percentage of participants]	38 131%	38 237.5%

2. Secondary Outcome

Title	Change in Urine pH
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Arm I: Alkaline Water	Arm II: Distilled Water
Arm/Group Description	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.	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.
Measure Participants	10	0
pH at baseline	5.6 (0.7)
pH at day 33 of treatment	6.1 (1.0)

Adverse Events

Time Frame	30 days after treatment
Arm/Group Title	Arm I: Alkaline Water		Arm II: Distilled Water
Arm/Group Description	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.		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.
All Cause Mortality
	Arm I: Alkaline Water		Arm II: Distilled Water
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I: Alkaline Water		Arm II: Distilled Water
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/29 (3.4%)		1/16 (6.3%)
Infections and infestations
Skin infection	0/29 (0%)	0	1/16 (6.3%)	1
Investigations
Alanine aminotransferase increased	1/29 (3.4%)	1	0/16 (0%)	0
Aspartate aminotransferase increased	1/29 (3.4%)	1	0/16 (0%)	0
Musculoskeletal and connective tissue disorders
Chest wall pain	1/29 (3.4%)	1	0/16 (0%)	0
Other (Not Including Serious) Adverse Events
	Arm I: Alkaline Water		Arm II: Distilled Water
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/29 (89.7%)		13/16 (81.3%)
Skin and subcutaneous tissue disorders
dermatitis	26/29 (89.7%)		13/16 (81.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.