Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
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|ClinicalTrials.gov Identifier: NCT01846429|
Recruitment Status : Terminated (Drugs unavailable. Study did not progress to Phase 2.)
First Posted : May 3, 2013
Last Update Posted : June 4, 2015
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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.
|Condition or disease||Intervention/treatment||Phase|
|Tumor Cancer Pain Malignant Solid Tumor Unresectable Malignant Neoplasm Hematologic Malignancy Multiple Myeloma Lymphoma Neoplasm Metastasis||Drug: Sodium Bicarbonate||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase I/II Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||May 2015|
Experimental: Sodium Bicarbonate Treatment
A 3+3 design for Phase I component and a two staged design for Phase II were to be used. Treatment: Sodium Bicarbonate Capsules (900 mg).
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.
- Phase I - Maximum Tolerated Dose (MTD) [ Time Frame: 4 weeks per participant ]
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.
- Phase II - Percent of Participants With Desired Response [ Time Frame: 4 weeks per participant ]
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.
- Pain Measurement Ranking [ Time Frame: 4 weeks per participant ]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.
- Quality of Life (QOL) [ Time Frame: 4 weeks per participant ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846429
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Amit Mahipal, M.D.||H. Lee Moffitt Cancer Center and Research Institute|
|Responsible Party:||H. Lee Moffitt Cancer Center and Research Institute|
|Other Study ID Numbers:||
|First Posted:||May 3, 2013 Key Record Dates|
|Last Update Posted:||June 4, 2015|
|Last Verified:||June 2015|
tumor related pain
cancer related pain
Neoplasms by Histologic Type
Immune System Diseases
Neoplasms, Plasma Cell
Blood Protein Disorders
Neoplasms by Site