Bicarbonate for Tumor Related Pain
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Pilot Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain|
- Percent of Patients With Improvement [ Time Frame: 4 weeks per participant ] [ Designated as safety issue: No ]Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale.
- Percent of Patients Where Treatment Was Well Tolerated [ Time Frame: 4 weeks per participant ] [ Designated as safety issue: Yes ]Tolerability and safety of oral sodium bicarbonate in patients with moderate to severe tumor related pain
- Number of Participants With Improvement in Pain Indices [ Time Frame: 4 weeks per participant ] [ Designated as safety issue: No ]Improvement in pain indices (Memorial Symptom Assessment Scale, MSAS) and Brief Pain Inventory (BPI).
|Study Start Date:||August 2010|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Sodium Bicarbonate Therapy
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.
The study is a single institution, non-randomized, single arm pilot study to evaluate the efficacy of adjuvant therapy with sodium bicarbonate for tumor related pain. Patients will receive sodium bicarbonate (0.15 g/kg/day for 1 weeks and if tolerated 0.3 g/kg/day for one week and if this dose is tolerated 0.6 g/kg/day) for 4 weeks. The sodium bicarbonate will be provided to the patient as a powder and consumed after it is mixed with about 250 cc (about 1 cup) of water. In consultation with the PI, the patients will be permitted to mix the sodium bicarbonate with a commercially available drink instead of water provided the liquid has an acid/base balance (pH) of 7.4 or greater. Patients with a good tolerance to study therapy and with at least a 30% improvement in pain intensity (by VAS) compared to baseline after 3 weeks of therapy and who wish to continue study therapy will be allowed to continue sodium bicarbonate therapy under the direction of their treating physician. Patients without at least a 30% improvement in pain intensity at 3 weeks will discontinue study therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350583
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Robert Gillies, Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|