Clinical trial · Interventional
Extended Use of Sodium Bicarbonate in Patients With Cancer
Chronic Oral Bicarbonate Feasibility Study
NCT02531919CI-TRIAL-00021723completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sodium Bicarbonate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sodium Bicarbonate
- description
- Dose concentration of 0.5 g/kg/day
- interventionNames
- Drug: Sodium Bicarbonate
Primary outcomes (1)
- measure
- Adherence measured by the time to evidence of adherence failure
- timeFrame
- 120 days
Secondary outcomes (1)
- measure
- Assessment of Metabolic Alkalosis by measurement of blood pH from basic metabolic panels
- timeFrame
- 120 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.