Extended Use of Sodium Bicarbonate in Patients With Cancer
- Registration Number
- NCT02531919
- Lead Sponsor
- University of Arizona
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Any cancer patient enrolled in the study must have a written approval from their oncologist that a notation will be made in the patient's chart for their study participation
- Subject without known cognitive impairment, central nervous system (CNS) metastasis, overt psychosis, major depression, or delirium as noted in the oncology medical record
- Subject with a Karnofsky performance status scale of 80% or greater at time of consent
- Subject has completed initial adjuvant therapy and is not currently receiving or waiting to receive chemotherapy during the next 120 days
- Breast cancer subjects may be enrolled if they are receiving hormonal blockade therapy
- Subject is not enrolled in any other clinical trials
- Subject has a valid working phone number to be contacted with during the study
- Subject must be willing to provide urine specimen for pH measurements during scheduled clinical visits
- Subject must be willing to provide a 3 mL blood sample for metabolic panels during scheduled clinical visits
- Subject does not have uncontrolled hypertension (systolic pressure > 140, diastolic pressure > 90) despite maximal anti-hypertensive therapy
- Subject has healthy renal function: creatinine clearance: 88-128 mL/min; glomerular filtration rate (GFR): > 90 mL/min/1.7m^2 based on standard care results no older than 2 weeks; if no data exist, the subject will need to consent to a blood draw for a basic metabolic panel (which measures creatinine) for verification
- Subject must be informed of the investigational nature of this study and must sign and written informed consent in accordance with institutional and federal guidelines
- Subject is not pregnant or breastfeeding at time of consent; a pregnancy test will be conducted from urine sample on day of consent in premenopausal women
- Subject agrees to use medically approved contraception (ie. condoms, oral contraceptive) if premenopausal
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sodium Bicarbonate Sodium Bicarbonate Dose concentration of 0.5 g/kg/day
- Primary Outcome Measures
Name Time Method Adherence measured by the time to evidence of adherence failure 120 days
- Secondary Outcome Measures
Name Time Method Assessment of Metabolic Alkalosis by measurement of blood pH from basic metabolic panels 120 days
Trial Locations
- Locations (1)
University of Arizona Medical Center-University Campus
🇺🇸Tucson, Arizona, United States