Extended Use of Sodium Bicarbonate in Patients With Cancer

Chronic Oral Bicarbonate Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Drug: Sodium Bicarbonate

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Medical Center-University Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sodium Bicarbonate; Dose concentration of 0.5 g/kg/day	Drug: Sodium Bicarbonate; Given PO; Other Names: NaHCO3; Baking Soda; Bicarbonate of Soda; Sodium Hydrogen Carbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adherence measured by the time to evidence of adherence failure	120 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of Metabolic Alkalosis by measurement of blood pH from basic metabolic panels	120 days

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Ian Robey, PhD, University of Arizona

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: August 20, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 25, 2015

Study Record Updates

• Last Update Posted (Estimate): April 13, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: tumor acidity
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 1300000483