Bicarbonate for Tumor Related Pain
|ClinicalTrials.gov Identifier: NCT01350583|
Recruitment Status : Terminated (PI Left Moffitt)
First Posted : May 10, 2011
Results First Posted : August 8, 2013
Last Update Posted : August 14, 2013
The purpose of this study is to:
- Determine how well people tolerated sodium bicarbonate taken by mouth in higher doses than those usually given for heartburn.
- Determine if sodium bicarbonate can reduce cancer-related pain. Right now, the investigators do not know for sure if these higher doses will be well tolerated or if they will reduce the pain associated with cancer. The investigators are doing this study to see if sodium bicarbonate is well tolerated and if it can reduce the requirements for pain medications.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Related Pain (Acute) (Chronic)||Drug: Sodium Bicarbonate (NaHCO3)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Pilot Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Experimental: Sodium Bicarbonate Therapy
Drug: Sodium Bicarbonate (NaHCO3)
Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated.
- Percent of Patients With Improvement [ Time Frame: 4 weeks per participant ]Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale.
- Percent of Patients Where Treatment Was Well Tolerated [ Time Frame: 4 weeks per participant ]Tolerability and safety of oral sodium bicarbonate in patients with moderate to severe tumor related pain
- Number of Participants With Improvement in Pain Indices [ Time Frame: 4 weeks per participant ]Improvement in pain indices (Memorial Symptom Assessment Scale, MSAS) and Brief Pain Inventory (BPI).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350583
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Robert Gillies, Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|