Trial Outcomes & Findings for Breakthrough Dyspnea Fentanyl Study in Cancer Patients (NCT NCT01515566)
NCT ID: NCT01515566
Last Updated: 2014-08-22
Results Overview
Retention rate is defined as the percentage of subjects able to complete the study.
COMPLETED
PHASE1/PHASE2
26 participants
Baseline to study completion, up to 100 minutes.
2014-08-22
Participant Flow
Outpatient participants from the Supportive Care Center at MD Anderson Cancer Center were recruited between July 10, 2012 and December 12, 2012.
Six participants of the 26 recruited were excluded from the trial before assignment to groups due to ineligibility.
Participant milestones
| Measure |
Fentanyl
Fentanyl subcutaneous (SQ) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl. Questionnaires completed at baseline and after study visit.
|
Placebo
Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Placebo. Questionnaires completed at baseline and after study visit.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Breakthrough Dyspnea Fentanyl Study in Cancer Patients
Baseline characteristics by cohort
| Measure |
Fentanyl
n=10 Participants
Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl or Placebo. Questionnaires completed at baseline and after study visit.
|
Placebo
n=10 Participants
Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl or Placebo. Questionnaires completed at baseline and after study visit.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to study completion, up to 100 minutes.Retention rate is defined as the percentage of subjects able to complete the study.
Outcome measures
| Measure |
Fentanyl
n=10 Participants
Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
|
Placebo
n=10 Participants
Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
|
|---|---|---|
|
Retention Rate
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 100 minutes for study participation.Participants receive either Fentanyl subcutaneous (SQ) 15 minutes before walking test, or Placebo (SQ) 15 minutes before walking test. During the study, trained research staff perform study assessments and monitor participant carefully throughout the study period. Six-minute walk tests were carried out following guidelines from the American Thoracic Society. The intensity of dyspnea at 0, 1, 2, 3, 4, 5 and 6 minute of each walk test were assessed using a validated numeric rating scale (NRS) ranging from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath") and every 5 minutes during the rest period.
Outcome measures
| Measure |
Fentanyl
n=10 Participants
Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
|
Placebo
n=10 Participants
Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
|
|---|---|---|
|
Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea
Dyspnea at 0 minutes (Baseline walk test)
|
2 units on a scale
Standard Deviation 1 • Interval 1.8 to 0.4
|
3 units on a scale
Standard Deviation 3 • Interval 1.5 to 0.1
|
|
Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea
Dyspnea at 6 minutes (Baseline walk test)
|
6 units on a scale
Standard Deviation 1 • Interval 3.2 to 0.4
|
7 units on a scale
Standard Deviation 3 • Interval 4.0 to 0.02
|
|
Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea
Dyspnea at 0 minutes (Second walk test)
|
1 units on a scale
Standard Deviation 1 • Interval 1.8 to 0.04
|
2 units on a scale
Standard Deviation 2 • Interval 1.5 to 0.1
|
|
Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea
Dyspnea at 6 minutes (Second walk test)
|
4 units on a scale
Standard Deviation 1 • Interval 3.2 to 0.4
|
5 units on a scale
Standard Deviation 3 • Interval 4.0 to 0.02
|
SECONDARY outcome
Timeframe: Baseline 6 minute walk test (6MWT) to second 6MWT, up to 100 minutes for study participation.Ambulatory patients with breakthrough dyspnea performed a baseline 6 minute walk test (6MWT), and then received either subcutaneous fentanyl or placebo 15 minutes before a second 6MWT. The change in walk distance was documented between the first and second 6MWT.
Outcome measures
| Measure |
Fentanyl
n=10 Participants
Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
|
Placebo
n=10 Participants
Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
|
|---|---|---|
|
Effect of Fentanyl on Walk Distance
Walk Distance (Second Walk Test)
|
434.9 feet
Standard Deviation 95.4
|
417.9 feet
Standard Deviation 89.3
|
|
Effect of Fentanyl on Walk Distance
Walk Distance (Baseline Walk Test)
|
397.7 feet
Standard Deviation 98.1
|
399 feet
Standard Deviation 86.4
|
Adverse Events
Fentanyl
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fentanyl
n=10 participants at risk
Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Fentanyl.
|
Placebo
n=10 participants at risk
Normal saline 0.9% preservative free SQ 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Placebo.
|
|---|---|---|
|
General disorders
Pain with subcutaneous injection
|
20.0%
2/10 • Number of events 2 • Adverse effect collection from baseline up to 100 minutes for study participation.
|
0.00%
0/10 • Adverse effect collection from baseline up to 100 minutes for study participation.
|
Additional Information
David Hui, MD, MSc, FRCPC / Asst. Professor, Palliative Care and Rehabilitation Medicine
University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place