NCT01846429

Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain

A Phase I/II Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (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 tolerate sodium bicarbonate taken by mouth in higher doses than those usually given for heartburn. * Determine if sodium bicarbonate can reduce cancer-related pain.

Detailed description

Single institution Phase I/II study of sodium bicarbonate in combination with standard medical management for patients with moderate to severe tumor related pain. Patients with metastatic solid malignancies and patients with hematologic malignancies with moderate to severe tumor related pain on a stable opioid regimen will be the subjects of this study.

Conditions

• Tumor
• Cancer
• Pain
• Malignant Solid Tumor
• Unresectable Malignant Neoplasm
• Hematologic Malignancy
• Multiple Myeloma
• Lymphoma
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Sodium Bicarbonate	Cohort 1 patients will take 10 capsules/day; cohort 2 patients will take 20 capsules/day; cohort 3 patients will take 30 capsules/day and cohort 4 patients will take 40 capsules/day. Cohort 2 - 4 patients will begin at the cohort 1 dose and dose escalate to their respective cohort doses in order to prevent any side effects associated with alkalosis. Dose escalation will occur at a rate of 10 capsules/week.

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-12-01
• Completion: 2015-05-01
• First posted: 2013-05-03
• Last updated: 2015-06-04

Locations

1 site across 1 country: United States