Extended Use of Sodium Bicarbonate in Patients With Cancer

University of Arizona

Status and phase

Completed

Phase 1

Conditions

Malignant Neoplasm

Treatments

Drug: Sodium Bicarbonate

Study type

Interventional

Funder types

Other

Identifiers

NCT02531919

1300000483

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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