NCT02531919

Extended Use of Sodium Bicarbonate in Patients With Cancer

Chronic Oral Bicarbonate Feasibility Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Sodium Bicarbonate	Given PO

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-11-01
• Completion: 2015-05-01
• First posted: 2015-08-25
• Last updated: 2016-04-13

Locations

1 site across 1 country: United States