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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
Collaborator:
Reliable Cancer Therapies
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01846429
First received: May 1, 2013
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.

Condition Intervention Phase
Tumor
Cancer
Pain
Malignant Solid Tumor
Unresectable Malignant Neoplasm
Hematologic Malignancy
Multiple Myeloma
Lymphoma
Neoplasm Metastasis
Drug: Sodium Bicarbonate
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 52
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 opioid regimen (at least 3 days of an opiate regimen).
  • 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 is NOT 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 who are receiving and or will receive, during their participation in study, an oral chemotherapeutic agent whose bioavailability could be altered by the ingestion of sodium bicarbonate
  • Patients receiving experimental therapy within 3 weeks of starting study treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01846429

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Nancy Burke    813-745-4616    nancy.burke@moffitt.org   
Principal Investigator: Amit Mahipal, M.D.         
Sub-Investigator: Robert Gillies, Ph.D.         
Sub-Investigator: Kim Jongphil, Ph.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Reliable Cancer Therapies
Investigators
Principal Investigator: Amit Mahipal, M.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01846429     History of Changes
Other Study ID Numbers: MCC-17136
Study First Received: May 1, 2013
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
cancer
pain fibers
acid levels
tumor related pain
cancer related pain
sodium bicarbonate
pain reliever
metastatic
unresectable
solid malignancy
hematologic malignancy
multiple myeloma
lymphoma

Additional relevant MeSH terms:
Neoplasms
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm Metastasis
Hematologic Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Neoplastic Processes
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on July 23, 2014