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A Preliminary Study of Prophylactic Fentanyl Pectin Nasal Spray (FPNS) for Exercise-Induced Breakthrough Dyspnea


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancers

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Trial Information

A Preliminary Study of Prophylactic Fentanyl Pectin Nasal Spray (FPNS) for Exercise-Induced Breakthrough Dyspnea


Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to receive either fentanyl or placebo. You will have an equal
chance of being assigned to either group. Neither you nor the study staff will know to
which group you have been assigned. However, if needed for your safety, the study staff
will be able to find out what you are receiving.

Study Drug/Placebo Administration:

Before you receive the study drug/placebo, you will walk back and forth in an indoor hallway
for up to 6 minutes. You may feel out of breath or become exhausted. You may slow down,
stop, and rest at any time you need to.

After that, you will sit down and rest (for about 30 minutes).

You will then be given the study drug/placebo by a nasal spray. You will then wait for
another 20 minutes and repeat the walking test.

After that, you will sit down and rest (for about 30 minutes).

You will then be given the study drug/placebo again by a nasal spray. You will then wait
for another 20 minutes and repeat the walking test for a third time.

Study Visit:

During your study visit, the study staff will collect information from your medical record
about your age, sex, race, disease type, your performance status, any drugs you are taking,
and possible causes of shortness of breath.

Before each walk test, you will complete the questionnaires about your symptoms.

Before and after each walk test, the study staff will record your heart rate, breathing
rate, and the level of oxygen in your blood using a measuring device that will be clipped
onto your finger. The study staff will also ask you 3 questions about how hard it is to
catch your breath and your level of tiredness.

During each walk test, you will be asked 6 times how hard it is to catch your breath. The
distance you walked and how often and for how long you stopped will be recorded.

Before and after the second and third walk tests, the study staff will ask you about any
side effects from the study drug/placebo that you may be having.

During the rest period between the walk tests, you may be asked several times how hard it is
to catch your breath.

After each walk test, you will also be asked to complete 4 tests of your mental abilities,
including finger tapping, simple mathematics questions (addition, subtraction,
multiplication, division), recall of numbers, and recall of objects. It should take 15
minutes to complete these tests.

At the end of the study visit, you will complete 1 questionnaire that asks if you think the
study drug/placebo is helping you, and how satisfied you are with the study. It should take
about 5 minutes to complete the questionnaire.

Length of Study:

You will be on this study for up to 3 hours. You will be taken off study if intolerable side
effects occur during the study.

This is an investigational study. Fentanyl is FDA approved and commercially available for
the treatment of pain. Its use to help with shortness of breath is investigational.

Up to 20 patients will be enrolled in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Diagnosis of cancer

2. Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average
intensity level >=3/10 on the numeric rating scale

3. Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service or
Thoracic Medical Oncology

4. Ambulatory and able to walk with or without walking aid

5. On strong opioids with morphine equivalent daily dose of 80-500 mg, with stable (i.e.
+/- 30%) regular dose over the last 24 hours

6. Karnofsky performance status >=50%

7. Age 18 or older

8. Able to complete study assessments

Exclusion Criteria:

1. Dyspnea at rest >=7/10 at the time of enrollment

2. Supplemental oxygen requirement >6 L per minute

3. Delirium (i.e. Memorial delirium rating scale >13)

4. History of unstable angina or myocardial infarction 1 month prior to study enrollment

5. Resting heart rate >120 at the time of study enrollment

6. Systolic pressure >180 mmHg or diastolic pressure >100 mmHg at the time of study
enrollment

7. History of active opioid abuse within the past 12 months

8. History of allergy to fentanyl

9. Unwilling to provide informed consent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Effect of Prophylactic Fentanyl Pectin Nasal Spray (FPNS)

Outcome Description:

The main goal of this study is to determine the effect size for both fentanyl pectin nasal spray (FPNS) and placebo arm. Comparisons within arms performed using paired t-tests or signed rank tests. Summary descriptive statistics will be provided for demographics, outcomes, and other collected variables and will include proportions, medians, means, 95% confidence intervals, and other simple statistics as appropriate for the measure.

Outcome Time Frame:

3 hours

Safety Issue:

No

Principal Investigator

David Hui, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2012-1169

NCT ID:

NCT01832402

Start Date:

June 2013

Completion Date:

Related Keywords:

  • Advanced Cancers
  • Advanced Cancers
  • Exercise-Induced Breakthrough Dyspnea
  • Shortness of breath
  • Fentanyl pectin nasal spray
  • Placebo nasal spray
  • Walk test
  • Questionnaires
  • Surveys
  • Mental ability tests
  • Dyspnea
  • Neoplasms

Name

Location

University of Texas MD Anderson Cancer CenterHouston, Texas  77030