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A Phase I/II Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain

Phase 1/Phase 2
18 Years
Not Enrolling
Tumor, Cancer, Pain, Malignant Solid Tumor, Unresectable Malignant Neoplasm, Hematologic Malignancy, Multiple Myeloma, Lymphoma, Neoplasm Metastasis

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Trial Information

A Phase I/II Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain

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.

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 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

- 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 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 months after stopping the

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 > 2.5mg/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

Type of Study:


Study Design:

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

Outcome Measure:

Phase I - Maximum Tolerated Dose (MTD)

Outcome Description:

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.

Outcome Time Frame:

4 weeks per participant

Safety Issue:


Principal Investigator

Amit Mahipal, M.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 2013

Completion Date:

July 2016

Related Keywords:

  • Tumor
  • Cancer
  • Pain
  • Malignant Solid Tumor
  • Unresectable Malignant Neoplasm
  • Hematologic Malignancy
  • Multiple Myeloma
  • Lymphoma
  • Neoplasm Metastasis
  • cancer
  • pain fibers
  • acid levels
  • tumor related pain
  • cancer related pain
  • sodium bicarbonate
  • pain reliever
  • metastatic
  • unresectable
  • solid malignancy
  • hematologic malignancy
  • multiple myeloma
  • lymphoma
  • Neoplasms
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neoplasm Metastasis
  • Hematologic Neoplasms



H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612