Clinical trial NCT02531919: Extended Use of Sodium Bicarbonate in Patients With Cancer
Official title: Chronic Oral Bicarbonate Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Neoplasm
Keywords: tumor acidity
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2015-08-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Adherence measured by the time to evidence of adherence failure
timeFrame: 120 days
Secondary outcomes:
measure: Assessment of Metabolic Alkalosis by measurement of blood pH from basic metabolic panels
timeFrame: 120 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Medical Center-University Campus
state: Arizona
Study officials:
affiliation: University of Arizona
name: Ian Robey, PhD
role: PRINCIPAL_INVESTIGATOR
References: