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

Primary Purpose

Tumor, Cancer, Pain

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sodium Bicarbonate
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tumor focused on measuring cancer, pain fibers, acid levels, tumor related pain, cancer related pain, sodium bicarbonate, pain reliever, metastatic, unresectable, solid malignancy, hematologic malignancy, multiple myeloma, lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have metastatic or unresectable solid malignancy or hematologic malignancy (multiple myeloma or lymphoma) and must have moderate to severe tumor related pain visual assessment scale (VAS)>4) on a stable or no opioid regimen (at least 3 days of an opiate regimen). VAS score should be greater than 4 at screening to be eligible.
  • No planned palliative surgery, palliative radiotherapy for at least 4 weeks. However prior radiotherapy, and surgery is allowed and not limited to the number of procedures and courses. Concomitant chemotherapy with agents indicated in protocol guidelines (Tables 10 and 11B, Appendix IV) is allowed.
  • No evidence of neurologic or psychiatric compromise which in the opinion of the investigator will interfere with completion of study assessments
  • Age greater than 18 years and able to understand and sign the informed consent document
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status less than 3.
  • A female patient and a male patient's female partner, of childbearing potential, must agree to use 2 adequate barrier methods of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting from Visit 1, while receiving protocol-specified medication, and for 1 month after stopping the medication.

Exclusion Criteria:

  • Patients with neuropathy and/or neuropathic pain as the only pain syndrome are not eligible.
  • Patients with only chronic non-malignant pain are not eligible.
  • Patients with renal insufficiency (creatinine > 2.5mg/dL) are excluded.
  • Patients with history of congestive heart failure or pulmonary artery hypertension will be excluded.
  • Patients with uncontrolled hypertension (systolic pressure >160, diastolic pressure >100) despite maximal antihypertensive therapy
  • Patients unable to ingest sodium bicarbonate capsules (such as patients with dysphagia or severe nausea)
  • Patients with ECOG performance status 3 or higher
  • Patients with acute leukemia, myelodysplastic syndrome, and chronic myeloid leukemia are not eligible.
  • Pregnant or lactating patients are not eligible.
  • Patients with known allergy to sodium bicarbonate or patients with preexisting renal or acid base disorders for which sodium bicarbonate is contraindicated (such as metabolic alkalosis, severe congestive heart failure, hypernatremia, and hypocalcemia (see above))
  • Patients with severe ongoing infections which places the patients at increased risks from therapy in the opinion of the investigator
  • Patients receiving concomitant chemotherapy with agents indicated in protocol guidelines (Tables 10 and 11B, Appendix IV) or target therapy intended to prolong life within 2 weeks of starting the study drug
  • Patients receiving experimental therapy within 2 weeks of starting study treatment

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sodium Bicarbonate Treatment

Arm Description

A 3+3 design for Phase I component and a two staged design for Phase II were to be used. Treatment: Sodium Bicarbonate Capsules (900 mg).

Outcomes

Primary Outcome Measures

Phase I - Maximum Tolerated Dose (MTD)
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
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.

Secondary Outcome Measures

Pain Measurement Ranking
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)
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.

Full Information

First Posted
May 1, 2013
Last Updated
June 2, 2015
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Reliable Cancer Therapies
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1. Study Identification

Unique Protocol Identification Number
NCT01846429
Brief Title
Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
Official Title
A Phase I/II Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Drugs unavailable. Study did not progress to Phase 2.
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Reliable Cancer Therapies

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor, Cancer, Pain, Malignant Solid Tumor, Unresectable Malignant Neoplasm, Hematologic Malignancy, Multiple Myeloma, Lymphoma, Neoplasm Metastasis
Keywords
cancer, pain fibers, acid levels, tumor related pain, cancer related pain, sodium bicarbonate, pain reliever, metastatic, unresectable, solid malignancy, hematologic malignancy, multiple myeloma, lymphoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium Bicarbonate Treatment
Arm Type
Experimental
Arm Description
A 3+3 design for Phase I component and a two staged design for Phase II were to be used. Treatment: Sodium Bicarbonate Capsules (900 mg).
Intervention Type
Drug
Intervention Name(s)
Sodium Bicarbonate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Phase I - Maximum Tolerated Dose (MTD)
Description
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.
Time Frame
4 weeks per participant
Title
Phase II - Percent of Participants With Desired Response
Description
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.
Time Frame
4 weeks per participant
Secondary Outcome Measure Information:
Title
Pain Measurement Ranking
Description
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.
Time Frame
4 weeks per participant
Title
Quality of Life (QOL)
Description
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.
Time Frame
4 weeks per participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have metastatic or unresectable solid malignancy or hematologic malignancy (multiple myeloma or lymphoma) and must have moderate to severe tumor related pain visual assessment scale (VAS)>4) on a stable or no opioid regimen (at least 3 days of an opiate regimen). VAS score should be greater than 4 at screening to be eligible. No planned palliative surgery, palliative radiotherapy for at least 4 weeks. However prior radiotherapy, and surgery is allowed and not limited to the number of procedures and courses. Concomitant chemotherapy with agents indicated in protocol guidelines (Tables 10 and 11B, Appendix IV) is allowed. No evidence of neurologic or psychiatric compromise which in the opinion of the investigator will interfere with completion of study assessments Age greater than 18 years and able to understand and sign the informed consent document Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status less than 3. A female patient and a male patient's female partner, of childbearing potential, must agree to use 2 adequate barrier methods of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting from Visit 1, while receiving protocol-specified medication, and for 1 month after stopping the medication. Exclusion Criteria: Patients with neuropathy and/or neuropathic pain as the only pain syndrome are not eligible. Patients with only chronic non-malignant pain are not eligible. Patients with renal insufficiency (creatinine > 2.5mg/dL) are excluded. Patients with history of congestive heart failure or pulmonary artery hypertension will be excluded. Patients with uncontrolled hypertension (systolic pressure >160, diastolic pressure >100) despite maximal antihypertensive therapy Patients unable to ingest sodium bicarbonate capsules (such as patients with dysphagia or severe nausea) Patients with ECOG performance status 3 or higher Patients with acute leukemia, myelodysplastic syndrome, and chronic myeloid leukemia are not eligible. Pregnant or lactating patients are not eligible. Patients with known allergy to sodium bicarbonate or patients with preexisting renal or acid base disorders for which sodium bicarbonate is contraindicated (such as metabolic alkalosis, severe congestive heart failure, hypernatremia, and hypocalcemia (see above)) Patients with severe ongoing infections which places the patients at increased risks from therapy in the opinion of the investigator Patients receiving concomitant chemotherapy with agents indicated in protocol guidelines (Tables 10 and 11B, Appendix IV) or target therapy intended to prolong life within 2 weeks of starting the study drug Patients receiving experimental therapy within 2 weeks of starting study treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Mahipal, M.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

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

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