Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
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.
Malignant Solid Tumor
Unresectable Malignant Neoplasm
Drug: Sodium Bicarbonate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Phase I/II Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain|
- Phase I - Maximum Tolerated Dose (MTD) [ Time Frame: 4 weeks per participant ] [ Designated as safety issue: Yes ]
To evaluate the safety (Phase I) of oral Sodium bicarbonate capsules as an adjuvant pain reliever in patients with tumor related moderate to severe pain.
To determine the maximum tolerated dose (MTD) of oral sodium bicarbonate capsules for patients with tumor related moderate to severe pain.
- Phase II - Percent of Participants With Desired Response [ Time Frame: 4 weeks per participant ] [ Designated as safety issue: No ]
Evaluate the efficacy (Phase II) of oral Sodium Bicarbonate capsules as an adjuvant pain reliever in patients with tumor related moderate to severe pain.
Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale at 4 weeks compared to baseline without a corresponding increase in opioid regimen. The response rate with 95% Clopper-Pearson confidence interval will be reported.
- Pain Measurement Ranking [ Time Frame: 4 weeks per participant ] [ Designated as safety issue: No ]Pain will be rated by the participant using a visual assessment scale (VAS) on a 0 to 10 scale. Mild Pain (1-4), Moderate Pain (5-6), Severe Pain (7-10). The change in pain between baseline and 4 weeks after treatment as measured by the VAS will be assessed using two-sided one-sample t-test or Wilcoxon signed-rank test, depending on whether normality assumption holds.
- Quality of Life (QOL) [ Time Frame: 4 weeks per participant ] [ Designated as safety issue: No ]Quality of life will be assessed using the Memorial Symptom Assessment Scale (MSAS) and Brief Pain Inventory (BPI). The change in score between baseline and 4 weeks after treatment will be compared using two-sided one-sample t-test or Wilcoxon signed-rank test, as appropriate.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Sodium Bicarbonate Treatment
A 3+3 design for Phase I component and a two staged design for Phase II will be used. Treatment will consist of Sodium Bicarbonate Capsules (930 mg).
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01846429
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Nancy Burke 813-745-4616 firstname.lastname@example.org|
|Principal Investigator: Amit Mahipal, M.D.|
|Sub-Investigator: Robert Gillies, Ph.D.|
|Sub-Investigator: Kim Jongphil, Ph.D.|
|Principal Investigator:||Amit Mahipal, M.D.||H. Lee Moffitt Cancer Center and Research Institute|