Bicarbonate for Tumor Related Pain

NCT01350583 | Terminated Results DMC

• 1 other identifier: MCC-16047
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

• Determine how well people tolerated sodium bicarbonate taken by mouth in higher doses than those usually given for heartburn.
• Determine if sodium bicarbonate can reduce cancer-related pain. Right now, the investigators do not know for sure if these higher doses will be well tolerated or if they will reduce the pain associated with cancer. The investigators are doing this study to see if sodium bicarbonate is well tolerated and if it can reduce the requirements for pain medications.

Conditions

Neoplasm Related Pain (Acute) (Chronic)

Keywords

tumor related pain

Outcome Measures

Primary Outcomes (1)

• Percent of Patients With Improvement

  Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale.

  4 weeks per participant

Secondary Outcomes (2)

• Percent of Patients Where Treatment Was Well Tolerated

  4 weeks per participant

• Number of Participants With Improvement in Pain Indices

  4 weeks per participant

Study Arms (1)

Sodium Bicarbonate Therapy

EXPERIMENTAL

Dose Escalation

Drug: Sodium Bicarbonate (NaHCO3)

Interventions

Sodium Bicarbonate (NaHCO3) DRUG

Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated.

Sodium Bicarbonate Therapy

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 (VAS\>4) on a stable opioid regimen (at least 3 days of an opiate regimen).
• No planned palliative surgery, palliative radiotherapy for at least 2 weeks. However prior radiotherapy, and surgery is allowed and not limited to the number of procedures and courses. Concomitant chemotherapy is allowed. In addition, when it is anticipated that chemotherapy may result in rapid pain relief (less than 2 weeks), patients will only be enrolled after completing their first cycle of chemotherapy and provided their pain level is greater than 4 on the VAS.
• No evidence of neurologic or psychiatric compromise which in the opinion of the investigator will interfere with completion of study assessments
• Life expectancy greater than 3 months
• 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 4.

You may not qualify if:

• Patients with neuropathy and/or neuropathic pain as the only pain syndrome are not eligible. Patients with chronic non malignant pain are not eligible.
• Patients with renal insufficiency (creatinine \> 2.5 mg/dL) are excluded
• Patients with history of congestive heart failure or pulmonary artery hypertension will be excluded
• Any patient who in the opinion of the investigator is dehydrated at the time of initial evaluation will be excluded.
• Patients with uncontrolled hypertension (systolic pressure \>140, diastolic pressure \>90) despite maximal antihypertensive therapy.
• Patients unable to ingest of oral sodium bicarbonate (such as patients with dysphagia or severe nausea)
• Patients with ECOG performance status 4
• Patients with acute leukemia, myelodysplastic syndrome, and chronic myeloid leukemia are not eligible.
• Pregnant or lactating patients are not eligible.
• Patients with estimated survival less than 3 months
• 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.

Sponsors & Collaborators

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

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

Cancer Pain

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This Pilot Supportive Care study ended prematurely due to slow accrual and the initiating principal investigator leaving the institution. The outcome measures were based on 25 evaluable participants and there were only 2 participants enrolled.

Results Point of Contact

• Title: Robert J. Gillies, Ph.D. - Principal Investigator
• Organization: H. Lee Moffitt Cancer Center and Research Institute

robert.gillies@moffitt.org

813-745-8355

Study Officials

• Robert Gillies, Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2011
• First Posted: May 10, 2011
• Study Start: August 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 14, 2013
• Results First Posted: August 8, 2013

Record last verified: 2013-06

Locations

US (1)