Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasm Metastasis

Lymphoma

Hematologic Neoplasms

Cancer Pain

Pain

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Neoplastic Processes

Neurologic Manifestations

Lymphosarcoma

Antipyretics

Analgesics

All Drugs and Chemicals

Acetaminophen

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).

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.

Sodium Bicarbonate

Amit Mahipal, M.D.

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.

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.

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

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

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.

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 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 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.

Reliable Cancer Therapies

H. Lee Moffitt Cancer Center and Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain	NCT01846429	Tumor Cancer Pain Malignant Solid... Unresectable Ma... Hematologic Mal... Multiple Myelom... Lymphoma Neoplasm Metast...	Sodium Bicarbon...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain	NCT01846429	Tumor Cancer Pain Malignant Solid... Unresectable Ma... Hematologic Mal... Multiple Myelom... Lymphoma Neoplasm Metast...	Sodium Bicarbon...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for pain fibers

Every month we try and update this database with for pain fibers cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pain fibers

Every month we try and update this database with for pain fibers cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pain fibers cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.