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A Pilot Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain

18 Years
Not Enrolling
Neoplasm Related Pain (Acute) (Chronic)

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Trial Information

A Pilot Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain

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 a 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.

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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Percent of Patients With Improvement

Outcome Description:

Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale at 3 weeks compared to baseline without a corresponding increase in opioid regimen.

Outcome Time Frame:

4 weeks per participant

Safety Issue:


Principal Investigator

Robert Gillies, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

May 2012

Related Keywords:

  • Neoplasm Related Pain (Acute) (Chronic)
  • tumor related pain
  • Neoplasms



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612