Extended Use of Sodium Bicarbonate in Patients With Cancer

Malignant Neoplasm Clinical Trial

Official title: Chronic Oral Bicarbonate Feasibility Study

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

• NCT number: NCT02531919
• Study type: Interventional
• Source: University of Arizona
• Status: Completed
• Phase: Phase 1
• Start date: August 2013
• Completion date: May 2015