Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01846429
• Other study ID #: MCC-17136
• Status: Terminated
• Phase: Phase 1
• First received: May 1, 2013
• Last updated: June 2, 2015
• Start date: September 2013
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: May 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Hematologic Malignancy
• Lymphoma
• Malignant Solid Tumor
• Multiple Myeloma
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Plasma Cell
• Pain
• Tumor
• Unresectable Malignant Neoplasm

Intervention

Drug:
• Sodium Bicarbonate
Cohort 1 patients will take 10 capsules/day; cohort 2 patients will take 20 capsules/day; cohort 3 patients will take 30 capsules/day and cohort 4 patients will take 40 capsules/day. Cohort 2 - 4 patients will begin at the cohort 1 dose and dose escalate to their respective cohort doses in order to prevent any side effects associated with alkalosis. Dose escalation will occur at a rate of 10 capsules/week.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Reliable Cancer Therapies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I - Maximum Tolerated Dose (MTD)	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.	4 weeks per participant	Yes
Primary	Phase II - Percent of Participants With Desired Response	Evaluate the efficacy (Phase II) of oral Sodium Bicarbonate capsules as an adjuvant pain reliever in patients with tumor related moderate to severe pain.; Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale at 4 weeks compared to baseline without a corresponding increase in opioid regimen. The response rate with 95% Clopper-Pearson confidence interval will be reported.	4 weeks per participant	No
Secondary	Pain Measurement Ranking	Pain will be rated by the participant using a visual assessment scale (VAS) on a 0 to 10 scale. Mild Pain (1-4), Moderate Pain (5-6), Severe Pain (7-10). The change in pain between baseline and 4 weeks after treatment as measured by the VAS will be assessed using two-sided one-sample t-test or Wilcoxon signed-rank test, depending on whether normality assumption holds.	4 weeks per participant	No
Secondary	Quality of Life (QOL)	Quality of life will be assessed using the Memorial Symptom Assessment Scale (MSAS) and Brief Pain Inventory (BPI). The change in score between baseline and 4 weeks after treatment will be compared using two-sided one-sample t-test or Wilcoxon signed-rank test, as appropriate.	4 weeks per participant	No

External Links

•   Moffitt Cancer Center Clinical Trials website