Bicarbonate for Tumor Related Pain

This study has been terminated.
(PI Left Moffitt)
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01350583
First received: May 6, 2011
Last updated: August 7, 2013
Last verified: June 2013
  Purpose

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.

Condition Intervention
Neoplasm Related Pain (Acute) (Chronic)
Drug: Sodium Bicarbonate (NaHCO3)

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 Pilot 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:
  • Percent of Patients With Improvement [ Time Frame: 4 weeks per participant ] [ Designated as safety issue: No ]
    Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale.


Secondary Outcome Measures:
  • Percent of Patients Where Treatment Was Well Tolerated [ Time Frame: 4 weeks per participant ] [ Designated as safety issue: Yes ]
    Tolerability and safety of oral sodium bicarbonate in patients with moderate to severe tumor related pain

  • Number of Participants With Improvement in Pain Indices [ Time Frame: 4 weeks per participant ] [ Designated as safety issue: No ]
    Improvement in pain indices (Memorial Symptom Assessment Scale, MSAS) and Brief Pain Inventory (BPI).


Enrollment: 2
Study Start Date: August 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium Bicarbonate Therapy
Dose Escalation
Drug: Sodium Bicarbonate (NaHCO3)
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.

Detailed Description:

The study is a single institution, non-randomized, single arm pilot study to evaluate the efficacy of adjuvant therapy with sodium bicarbonate for tumor related pain. Patients will receive sodium bicarbonate (0.15 g/kg/day for 1 weeks and if tolerated 0.3 g/kg/day for one week and if this dose is tolerated 0.6 g/kg/day) for 4 weeks. The sodium bicarbonate will be provided to the patient as a powder and consumed after it is mixed with about 250 cc (about 1 cup) of water. In consultation with the PI, the patients will be permitted to mix the sodium bicarbonate with a commercially available drink instead of water provided the liquid has an acid/base balance (pH) of 7.4 or greater. Patients with a good tolerance to study therapy and with at least a 30% improvement in pain intensity (by VAS) compared to baseline after 3 weeks of therapy and who wish to continue study therapy will be allowed to continue sodium bicarbonate therapy under the direction of their treating physician. Patients without at least a 30% improvement in pain intensity at 3 weeks will discontinue study therapy.

  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 (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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350583

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Robert Gillies, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01350583     History of Changes
Other Study ID Numbers: MCC-16047
Study First Received: May 6, 2011
Results First Received: June 5, 2013
Last Updated: August 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
tumor related pain

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 22, 2014