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Extended Use of Sodium Bicarbonate in Patients With Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT02531919
First received: August 20, 2015
Last updated: April 12, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Malignant Neoplasm
Drug: Sodium Bicarbonate
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Chronic Oral Bicarbonate Feasibility Study

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Adherence measured by the time to evidence of adherence failure [ Time Frame: 120 days ]

Secondary Outcome Measures:
  • Assessment of Metabolic Alkalosis by measurement of blood pH from basic metabolic panels [ Time Frame: 120 days ]

Enrollment: 15
Study Start Date: August 2013
Study Completion Date: May 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium Bicarbonate
Dose concentration of 0.5 g/kg/day
Drug: Sodium Bicarbonate
Given PO
Other Names:
  • Baking Soda
  • Bicarbonate of Soda
  • NaHCO3
  • Sodium Hydrogen Carbonate

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02531919

Locations
United States, Arizona
University of Arizona Medical Center-University Campus
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Ian Robey, PhD University of Arizona
  More Information

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT02531919     History of Changes
Other Study ID Numbers: 1300000483
Study First Received: August 20, 2015
Last Updated: April 12, 2016

Keywords provided by University of Arizona:
tumor acidity

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 25, 2017