A Pilot Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
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 a 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
Percent of Patients With Improvement
Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale at 3 weeks compared to baseline without a corresponding increase in opioid regimen.
4 weeks per participant
Robert Gillies, Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|