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Extended Use of Sodium Bicarbonate in Patients With Cancer

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ClinicalTrials.gov Identifier: NCT02531919
Recruitment Status : Completed
First Posted : August 25, 2015
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Drug: Sodium Bicarbonate Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chronic Oral Bicarbonate Feasibility Study
Study Start Date : August 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT02531919     History of Changes
Other Study ID Numbers: 1300000483
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016

Keywords provided by University of Arizona:
tumor acidity

Additional relevant MeSH terms:
Neoplasms