Clinical trial NCT01846429: Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
Official title: A Phase I/II Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
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
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Reliable Cancer Therapies
First posted: 2013-05-03
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility 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 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Phase I - Maximum Tolerated Dose (MTD)
timeFrame: 4 weeks per participant
measure: Phase II - Percent of Participants With Desired Response
timeFrame: 4 weeks per participant
Secondary outcomes:
measure: Pain Measurement Ranking
timeFrame: 4 weeks per participant
measure: Quality of Life (QOL)
timeFrame: 4 weeks per participant
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Amit Mahipal, M.D.
role: PRINCIPAL_INVESTIGATOR
References: