Extended Use of Sodium Bicarbonate in Patients With Cancer
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Chronic Oral Bicarbonate Feasibility Study|
- Adherence measured by the time to evidence of adherence failure [ Time Frame: 120 days ]
- Assessment of Metabolic Alkalosis by measurement of blood pH from basic metabolic panels [ Time Frame: 120 days ]
|Study Start Date:||August 2013|
|Study Completion Date:||May 2015|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Sodium Bicarbonate
Dose concentration of 0.5 g/kg/day
Drug: Sodium Bicarbonate
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02531919
|United States, Arizona|
|University of Arizona Medical Center-University Campus|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Ian Robey, PhD||University of Arizona|