Extended Use of Sodium Bicarbonate in Patients With Cancer

NCT02531919 | Completed Phase 1 DMC

• 1 other identifier: 1300000483
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Keywords

tumor acidity

Outcome Measures

Primary Outcomes (1)

• Adherence measured by the time to evidence of adherence failure

  120 days

Secondary Outcomes (1)

• Assessment of Metabolic Alkalosis by measurement of blood pH from basic metabolic panels

  120 days

Study Arms (1)

Sodium Bicarbonate

EXPERIMENTAL

Dose concentration of 0.5 g/kg/day

Drug: Sodium Bicarbonate

Interventions

Sodium Bicarbonate DRUG

Given PO

Also known as: Baking Soda, Bicarbonate of Soda, NaHCO3, Sodium Hydrogen Carbonate

Sodium Bicarbonate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Medical Center-University Campus

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ian Robey, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 25, 2015
• Study Start: August 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: May 1, 2015
• Last Updated: April 13, 2016

Record last verified: 2016-04

Locations

US (1)