Extended Use of Sodium Bicarbonate in Patients With Cancer
Completed · Phase 1
Conditions studied: Malignant Neoplasm
In brief
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.
Key facts
- Study ID
- NCT02531919
- Run by
- University of Arizona
- People needed
- 15
- Starts
- 2013-08-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2016-04-13
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- University of Arizona Medical Center-University Campus — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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