Extended Use of Sodium Bicarbonate in Patients With Cancer

NCT ID: NCT02531919

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-05-31

Brief Summary

This pilot phase I trial studies the safety of long-term use of sodium bicarbonate in patients with cancer. Sodium bicarbonate may neutralize tumor acidity and as a result may inhibit the spread of the tumor to other parts of the body (metastases) and improve survival.

Detailed Description

PRIMARY OBJECTIVES:

I. Determine if the dose concentration of 0.5 g/kg/day sodium bicarbonate is feasible and well tolerated as measured by the proportion of subjects with first evidence of adherence failure.

SECONDARY OBJECTIVES:

I. Determine if the dose concentration of 0.5 g/kg/day sodium bicarbonate is safe for long term consumption (90 days) as measured by blood pressure, resting pulse rate, and basic metabolic panels to assess metabolic alkalosis.

OUTLINE:

PHASE I (RUN-IN/ADJUSTMENT): Patients receive sodium bicarbonate orally (PO) dissolved in water thrice daily (TID) or twice daily (BID) on days 1-10. The dose may be adjusted as necessary.

PHASE II (LONG TERM): Patients continue to receive sodium bicarbonate PO TID or BID for a total of 90 days in the absence of disease progression or unacceptable toxicity.

Conditions

Malignant Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sodium Bicarbonate

Dose concentration of 0.5 g/kg/day

Group Type: EXPERIMENTAL

Sodium Bicarbonate

Intervention Type: DRUG

Given PO

Interventions

Sodium Bicarbonate

Given PO

Intervention Type: DRUG

Other Intervention Names

Baking Soda; Bicarbonate of Soda; NaHCO3; Sodium Hydrogen Carbonate

Eligibility Criteria

Inclusion Criteria

• Any cancer patient enrolled in the study must have a written approval from their oncologist that a notation will be made in the patient's chart for their study participation
• Subject without known cognitive impairment, central nervous system (CNS) metastasis, overt psychosis, major depression, or delirium as noted in the oncology medical record
• Subject with a Karnofsky performance status scale of 80% or greater at time of consent
• Subject has completed initial adjuvant therapy and is not currently receiving or waiting to receive chemotherapy during the next 120 days
• Breast cancer subjects may be enrolled if they are receiving hormonal blockade therapy
• Subject is not enrolled in any other clinical trials
• Subject has a valid working phone number to be contacted with during the study
• Subject must be willing to provide urine specimen for pH measurements during scheduled clinical visits
• Subject must be willing to provide a 3 mL blood sample for metabolic panels during scheduled clinical visits
• Subject does not have uncontrolled hypertension (systolic pressure > 140, diastolic pressure > 90) despite maximal anti-hypertensive therapy
• Subject has healthy renal function: creatinine clearance: 88-128 mL/min; glomerular filtration rate (GFR): > 90 mL/min/1.7m^2 based on standard care results no older than 2 weeks; if no data exist, the subject will need to consent to a blood draw for a basic metabolic panel (which measures creatinine) for verification
• Subject must be informed of the investigational nature of this study and must sign and written informed consent in accordance with institutional and federal guidelines
• Subject is not pregnant or breastfeeding at time of consent; a pregnancy test will be conducted from urine sample on day of consent in premenopausal women
• Subject agrees to use medically approved contraception (ie. condoms, oral contraceptive) if premenopausal

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Robey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona Medical Center-University Campus

Tucson, Arizona, United States

Countries

United States

Other Identifiers

1300000483

Identifier Type: -

Identifier Source: org_study_id