NCT01350583

Bicarbonate for Tumor Related Pain

A Pilot Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Neoplasm Related Pain (Acute) (Chronic)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-05-10
• Last updated: 2013-08-14
• Results posted: 2013-08-08

Locations

1 site across 1 country: United States