Neoplasm Related Pain (Acute) (Chronic) Clinical Trial
Official title:
A Pilot Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With 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.
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. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care