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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Bicarbonate | Experimental | Dose concentration of 0.5 g/kg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Bicarbonate | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence measured by the time to evidence of adherence failure | 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Metabolic Alkalosis by measurement of blood pH from basic metabolic panels | 120 days |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Robey, PhD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Medical Center-University Campus | Tucson | Arizona | 85724 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |