Trial Outcomes & Findings for Buspirone in Reducing Shortness of Breath in Patients With Cancer (NCT NCT00053846)
NCT ID: NCT00053846
Last Updated: 2015-11-24
Results Overview
OCD was used to evaluate dyspnea on exertion and activities of daily living. OCD is a visual analog scale for quantifying a patient's evaluation of tolerance of exertion, which corresponds to oxygen requirements at different activity levels. It is measured as a score of 2 (sleeping) to 14 (brisk walking uphill). HIgher scores indicate fewer limitations due to dyspnea.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
432 participants
Primary outcome timeframe
28 days after beginning study drug or placebo
Results posted on
2015-11-24
Participant Flow
Participant milestones
| Measure |
Buspirone Hydrochloride
buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
|
Placebo
Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
|
|---|---|---|
|
Overall Study
STARTED
|
213
|
219
|
|
Overall Study
COMPLETED
|
187
|
192
|
|
Overall Study
NOT COMPLETED
|
26
|
27
|
Reasons for withdrawal
| Measure |
Buspirone Hydrochloride
buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
|
Placebo
Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
|
|---|---|---|
|
Overall Study
Changed mind
|
8
|
13
|
|
Overall Study
Became too ill
|
8
|
7
|
|
Overall Study
Expired
|
5
|
0
|
|
Overall Study
Became ineligible
|
3
|
1
|
|
Overall Study
Did not return data
|
1
|
2
|
|
Overall Study
Quit due to side effects
|
1
|
3
|
|
Overall Study
Pills too large
|
0
|
1
|
Baseline Characteristics
Buspirone in Reducing Shortness of Breath in Patients With Cancer
Baseline characteristics by cohort
| Measure |
Buspirone Hydrochloride
n=187 Participants
buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
|
Placebo
n=192 Participants
Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
|
Total
n=379 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
White
|
166 participants
n=5 Participants
|
171 participants
n=7 Participants
|
337 participants
n=5 Participants
|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
181 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
370 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Marital Status
Married
|
127 participants
n=5 Participants
|
126 participants
n=7 Participants
|
253 participants
n=5 Participants
|
|
Marital Status
Not Married
|
60 participants
n=5 Participants
|
66 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Education
Beyond High School
|
76 participants
n=5 Participants
|
78 participants
n=7 Participants
|
154 participants
n=5 Participants
|
|
Education
High School or Less
|
111 participants
n=5 Participants
|
114 participants
n=7 Participants
|
225 participants
n=5 Participants
|
|
History of chronic obstructive pulmonary disease (COPD)
Yes
|
28 participants
n=5 Participants
|
69 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
History of chronic obstructive pulmonary disease (COPD)
No
|
159 participants
n=5 Participants
|
123 participants
n=7 Participants
|
282 participants
n=5 Participants
|
|
Tumor Site
Lung
|
114 participants
n=5 Participants
|
118 participants
n=7 Participants
|
232 participants
n=5 Participants
|
|
Tumor Site
Breast
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Tumor Site
Gastrointestinal
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Tumor Site
Other
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Tumor Stage
I
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Tumor Stage
II
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Tumor Stage
III
|
49 participants
n=5 Participants
|
53 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Tumor Stage
IV
|
103 participants
n=5 Participants
|
102 participants
n=7 Participants
|
205 participants
n=5 Participants
|
|
Tumor Stage
Unknown
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
O2 Cost Diagram (OCD)
|
8.70 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
8.43 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
8.56 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade
0
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade
1
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade
2
|
77 participants
n=5 Participants
|
80 participants
n=7 Participants
|
157 participants
n=5 Participants
|
|
Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade
3
|
61 participants
n=5 Participants
|
54 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade
4
|
22 participants
n=5 Participants
|
32 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Modified Medical Research Council Dyspnea Scale (MMRCDS) Grade
Unknown
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days after beginning study drug or placeboOCD was used to evaluate dyspnea on exertion and activities of daily living. OCD is a visual analog scale for quantifying a patient's evaluation of tolerance of exertion, which corresponds to oxygen requirements at different activity levels. It is measured as a score of 2 (sleeping) to 14 (brisk walking uphill). HIgher scores indicate fewer limitations due to dyspnea.
Outcome measures
| Measure |
Buspirone Hydrochloride
n=187 Participants
buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
|
Placebo
n=192 Participants
Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
|
|---|---|---|
|
Dyspnea as Measured by Oxygen Cost Diagram (OCD)
|
8.98 units on a scale
Standard Deviation 2.85
|
9.32 units on a scale
Standard Deviation 2.62
|
Adverse Events
Buspirone Hydrochloride
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Buspirone Hydrochloride
n=213 participants at risk
buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
|
Placebo
n=219 participants at risk
Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
|
|---|---|---|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/213
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
Breathlessness & Chest Pressure
|
0.47%
1/213
|
0.00%
0/219
|
|
General disorders
Anemia & pleural effusion, inc SOB
|
0.47%
1/213
|
0.00%
0/219
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.47%
1/213
|
0.46%
1/219
|
|
General disorders
Scrotal pain/swelling; hypoxia; death
|
0.00%
0/213
|
0.46%
1/219
|
|
General disorders
Death
|
0.94%
2/213
|
1.4%
3/219
|
Other adverse events
| Measure |
Buspirone Hydrochloride
n=213 participants at risk
buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
|
Placebo
n=219 participants at risk
Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
|
|---|---|---|
|
Nervous system disorders
Dizziness, confusion; insomnia
|
0.94%
2/213
|
0.91%
2/219
|
|
Gastrointestinal disorders
GI Bleed
|
0.00%
0/213
|
0.46%
1/219
|
|
General disorders
Aching hands and back
|
0.00%
0/213
|
0.46%
1/219
|
|
Gastrointestinal disorders
Nausea and vomitting
|
1.4%
3/213
|
0.46%
1/219
|
|
General disorders
Disease progression
|
0.00%
0/213
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
3/213
|
0.91%
2/219
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/213
|
1.4%
3/219
|
|
Nervous system disorders
Confusion
|
0.47%
1/213
|
0.00%
0/219
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.47%
1/213
|
0.00%
0/219
|
|
General disorders
Shakes and tremors
|
0.00%
0/213
|
0.91%
2/219
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.47%
1/213
|
0.00%
0/219
|
|
Infections and infestations
Pneumonia/bronchitis
|
0.47%
1/213
|
0.00%
0/219
|
|
Blood and lymphatic system disorders
Low platelet count
|
0.47%
1/213
|
0.00%
0/219
|
|
Blood and lymphatic system disorders
Hypoxemia
|
0.47%
1/213
|
0.00%
0/219
|
|
Blood and lymphatic system disorders
Orthostatis hypotension
|
0.00%
0/213
|
0.46%
1/219
|
|
Blood and lymphatic system disorders
Thrombosis
|
0.47%
1/213
|
0.00%
0/219
|
Additional Information
Charles E. Heckler, PhD, MS. Research Assistant Professor
University of Rochester Medical Center
Phone: 585-273-1141
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place