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

NCT01846429 | Terminated Phase 1

• 1 other identifier: MCC-17136
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  4 weeks per participant

• 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.

  4 weeks per participant

Secondary Outcomes (2)

• Pain Measurement Ranking

  4 weeks per participant

• Quality of Life (QOL)

  4 weeks per participant

Study Arms (1)

Sodium Bicarbonate Treatment

EXPERIMENTAL

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).

Drug: Sodium Bicarbonate

Interventions

Sodium Bicarbonate DRUG

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.

Sodium Bicarbonate Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Reliable Cancer Therapies: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Gillies RJ, Ibrahim-Hashim A, Ordway B, Gatenby RA. Back to basic: Trials and tribulations of alkalizing agents in cancer. Front Oncol. 2022 Nov 14;12:981718. doi: 10.3389/fonc.2022.981718. eCollection 2022.

  PMID: 36452492 DERIVED

MeSH Terms

Conditions

Neoplasms; Pain; Hematologic Neoplasms; Multiple Myeloma; Lymphoma; Neoplasm Metastasis; Cancer Pain

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases; Neoplastic Processes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Amit Mahipal, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 3, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

US (1)