Trial Outcomes & Findings for Bicarbonate for Tumor Related Pain (NCT NCT01350583)

Results Overview

Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

4 weeks per participant

Results posted on

2013-08-14

Participant Flow

This study was open to enrollment at Moffitt Cancer Center from August, 2010 through July, 2011. Two participants were actually enrolled during 2010.

Participant milestones

Participant milestones
Measure	Sodium Bicarbonate Therapy Dose Escalation 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.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bicarbonate for Tumor Related Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sodium Bicarbonate Therapy n=2 Participants Dose Escalation 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks per participant

Population: Results data was not calculated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.

Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks per participant

Population: Results data was not tabulated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.

Tolerability and safety of oral sodium bicarbonate in patients with moderate to severe tumor related pain

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks per participant

Population: Results data was not tabulated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.

Improvement in pain indices (Memorial Symptom Assessment Scale, MSAS) and Brief Pain Inventory (BPI).

Outcome measures

Outcome data not reported

Adverse Events

Sodium Bicarbonate Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sodium Bicarbonate Therapy n=2 participants at risk Dose Escalation 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.
Gastrointestinal disorders Nausea	50.0% 1/2 • Number of events 1 • 10 weeks
Gastrointestinal disorders Vomiting	50.0% 1/2 • Number of events 1 • 10 weeks
Blood and lymphatic system disorders Edema: head and neck	50.0% 1/2 • Number of events 1 • 10 weeks
Blood and lymphatic system disorders Edema: limb	50.0% 1/2 • Number of events 3 • 10 weeks
General disorders Pain - Head/headache	50.0% 1/2 • Number of events 1 • 10 weeks

Additional Information

Robert J. Gillies, Ph.D. - Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-8355

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place