Trial Outcomes & Findings for Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea (NCT NCT01856114)
NCT ID: NCT01856114
Last Updated: 2020-09-16
Results Overview
Our primary outcome was dyspnea intensity "now" using a dyspnea numeric rating scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference between the baseline and second 6 minute walk test. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Baseline to 30 minutes
Results posted on
2020-09-16
Participant Flow
Adult participants (age\>18) with an active diagnosis of cancer were recruited between May 2014 to May 2016 from the Supportive Care Center outpatient clinic of MD Anderson Cancer Center who met the inclusion and exclusion criteria.
A total of 36 participants enrolled. 22 patients were randomized, 14 patients dropped out before randomization, 3 participants died, 4 had declining Karnofsky Performance Score/hospice, 2 participant's Morphine equivalent daily dose was no longer in range, 1 participant declined and 4 participants were no longer interested in the study.
Participant milestones
| Measure |
Intervention Group (Fentanyl Buccal Tablet)
Received Fentanyl Buccal Tablet 30 minutes before 2nd 6 minute walk test, dose equivalent to 20-50% of their total opioid dose over the past 24 hours.
|
Controlled Group (Placebo)
Received Placebo tablet 30 minutes before 2nd 6 minute walk test.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Intervention Group (Fentanyl Buccal Tablet)
Received Fentanyl Buccal Tablet 30 minutes before 2nd 6 minute walk test, dose equivalent to 20-50% of their total opioid dose over the past 24 hours.
|
Controlled Group (Placebo)
Received Placebo tablet 30 minutes before 2nd 6 minute walk test.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea
Baseline characteristics by cohort
| Measure |
Intervention Group (Fentanyl Buccal Tablet)
n=9 Participants
Received Fentanyl Buccal Tablet 30 minutes before 2nd 6 minute walk test, dose equivalent to 20-50% of their total opioid dose over the past 24 hours.
|
Controlled Group (Placebo)
n=11 Participants
Received Placebo tablet 30 minutes before 2nd 6 minute walk test.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Education
College and above
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Cancer Stage
Metastatic Stage
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Cancer Stage
Locally Advanced
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Cancer Type
Lung Cancer
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Cancer Type
Breast Cancer
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Cancer Type
Gastrointestinal Cancer
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Cancer Type
Genitourinary Cancer
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Cancer Type
Other
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Cancer Type
Gynecologic Cancer
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Continuous
|
52 years
n=93 Participants
|
57 years
n=4 Participants
|
55 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=93 Participants
|
11 participants
n=4 Participants
|
20 participants
n=27 Participants
|
|
Education
High School or less
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to 30 minutesOur primary outcome was dyspnea intensity "now" using a dyspnea numeric rating scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference between the baseline and second 6 minute walk test. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.
Outcome measures
| Measure |
Intervention Group (Fentanyl Buccal Tablet)
n=9 Participants
Received Fentanyl Buccal Tablet 30 minutes before 2nd 6 minute walk test, dose equivalent to 20-50% of their total opioid dose over the past 24 hours.
|
Controlled Group (Placebo)
n=11 Participants
Received Placebo tablet 30 minutes before 2nd 6 minute walk test.
|
|---|---|---|
|
Dyspnea Numeric Rating Scale
|
-2.4 score on a scale
Interval -3.5 to -1.3
|
-1.1 score on a scale
Interval -2.5 to 0.2
|
SECONDARY outcome
Timeframe: Baseline to 30 minutesAssessed dyspnea using the 0-10 modified Dyspnea Borg Scale at baseline walk test and after second 6 minute walk test. The Borg scale ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference between the baseline walk test and second 6 minute walk test.
Outcome measures
| Measure |
Intervention Group (Fentanyl Buccal Tablet)
n=9 Participants
Received Fentanyl Buccal Tablet 30 minutes before 2nd 6 minute walk test, dose equivalent to 20-50% of their total opioid dose over the past 24 hours.
|
Controlled Group (Placebo)
n=11 Participants
Received Placebo tablet 30 minutes before 2nd 6 minute walk test.
|
|---|---|---|
|
Dyspnea Borg Scale
|
-1.6 score on a scale
Interval -2.9 to -0.3
|
-0.5 score on a scale
Interval -1.9 to 0.8
|
SECONDARY outcome
Timeframe: Baseline to 30 minutesMeasured the mean difference between the baseline walk test and second 6 minute walk test.
Outcome measures
| Measure |
Intervention Group (Fentanyl Buccal Tablet)
n=9 Participants
Received Fentanyl Buccal Tablet 30 minutes before 2nd 6 minute walk test, dose equivalent to 20-50% of their total opioid dose over the past 24 hours.
|
Controlled Group (Placebo)
n=11 Participants
Received Placebo tablet 30 minutes before 2nd 6 minute walk test.
|
|---|---|---|
|
Walk Distance at 6 Minutes
|
-1 meters
Interval -22.3 to 20.3
|
6.7 meters
Interval -3.4 to 16.9
|
Adverse Events
Intervention Group (Fentanyl Buccal Tablet)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controlled Group (Placebo)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group (Fentanyl Buccal Tablet)
n=9 participants at risk
Received Fentanyl Buccal Tablet 30 minutes before 2nd 6 minute walk test, dose equivalent to 20-50% of their total opioid dose over the past 24 hours.
|
Controlled Group (Placebo)
n=11 participants at risk
Received Placebo tablet 30 minutes before 2nd 6 minute walk test.
.
|
|---|---|---|
|
Nervous system disorders
Dizzy
|
0.00%
0/9 • Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) immediate before drug administration and immediately after the second 6 minute walk test (approximately 30 minutes later).
|
18.2%
2/11 • Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) immediate before drug administration and immediately after the second 6 minute walk test (approximately 30 minutes later).
|
|
Nervous system disorders
Drowsy
|
0.00%
0/9 • Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) immediate before drug administration and immediately after the second 6 minute walk test (approximately 30 minutes later).
|
18.2%
2/11 • Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) immediate before drug administration and immediately after the second 6 minute walk test (approximately 30 minutes later).
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
0.00%
0/9 • Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) immediate before drug administration and immediately after the second 6 minute walk test (approximately 30 minutes later).
|
18.2%
2/11 • Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) immediate before drug administration and immediately after the second 6 minute walk test (approximately 30 minutes later).
|
Additional Information
Dr. David Hui, MD, Associate Professor, Palliative Care Medicine
UT MD Anderson Cancer Center
Phone: 713-792-6258
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place