Extended Use of Sodium Bicarbonate in Patients With Cancer

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona

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