Extended Use of Sodium Bicarbonate in Patients With Cancer

Malignant Neoplasm Clinical Trial

Official title:

Chronic Oral Bicarbonate Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531919
• Other study ID #: 1300000483
• Status: Completed
• Phase: Phase 1
• First received: August 20, 2015
• Last updated: April 12, 2016
• Start date: August 2013
• Est. completion date: May 2015

Study information

• Verified date: April 2016
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Drug:
• Sodium Bicarbonate
Given PO

Locations

Country	Name	City	State
United States	University of Arizona Medical Center-University Campus	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence measured by the time to evidence of adherence failure		120 days	Yes
Secondary	Assessment of Metabolic Alkalosis by measurement of blood pH from basic metabolic panels		120 days	Yes