Bicarbonate for Tumor Related Pain
NCT01350583 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2013-08-14
Summary
The purpose of this study is to:
* Determine how well people tolerated sodium bicarbonate taken by mouth in higher doses than those usually given for heartburn.
* Determine if sodium bicarbonate can reduce cancer-related pain. Right now, the investigators do not know for sure if these higher doses will be well tolerated or if they will reduce the pain associated with cancer. The investigators are doing this study to see if sodium bicarbonate is well tolerated and if it can reduce the requirements for pain medications.
Conditions
- Neoplasm Related Pain (Acute) (Chronic)
Interventions
- DRUG
-
Sodium Bicarbonate (NaHCO3)
Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated.
Sponsors & Collaborators
-
H. Lee Moffitt Cancer Center and Research Institute
lead OTHER
Principal Investigators
-
Robert Gillies, Ph.D. · H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-08-31
- Primary Completion
- 2012-05-31
- Completion
- 2012-05-31
Countries
- United States
Study Locations
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