Extended Use of Sodium Bicarbonate in Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT02531919|
Recruitment Status : Completed
First Posted : August 25, 2015
Last Update Posted : April 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm||Drug: Sodium Bicarbonate||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chronic Oral Bicarbonate Feasibility Study|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||May 2015|
Experimental: Sodium Bicarbonate
Dose concentration of 0.5 g/kg/day
Drug: Sodium Bicarbonate
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531919
|United States, Arizona|
|University of Arizona Medical Center-University Campus|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Ian Robey, PhD||University of Arizona|