Clinical trial NCT01832402: Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea
Official title: A Preliminary Study of Prophylactic Fentanyl Pectin Nasal Spray (FPNS) for Exercise-Induced Breakthrough Dyspnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Cancers
Keywords: Advanced Cancers
Exercise-Induced Breakthrough Dyspnea
Shortness of breath
Fentanyl pectin nasal spray
Placebo nasal spray
Walk test
Questionnaires
Surveys
Mental ability tests
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Depomed
First posted: 2013-04-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical research study is to learn if fentanyl nasal spray can help to control shortness of breath in patients who have been treated or are being treated for cancer.

Fentanyl is commonly used for treatment of cancer pain. It may help patients with their shortness of breath as well.

In this study, fentanyl will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Detailed description: 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 25 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Eligibility criteria: 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
10. Patients who currently have no evidence of disease

Primary outcomes:
measure: Dyspnea Numeric Rating Scale
timeFrame: 1.5 to 2 hours on a Single visit
Secondary outcomes:
measure: Dyspnea Borg Scale
timeFrame: 1.5 to 2 hours on a Single visit
measure: Walk Distance at 6 Minutes
timeFrame: 1.5 to 2 hours on a Single visit
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David Hui, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hui D, Kilgore K, Park M, Williams J, Liu D, Bruera E. Impact of Prophylactic Fentanyl Pectin Nasal Spray on Exercise-Induced Episodic Dyspnea in Cancer Patients: A Double-Blind, Randomized Controlled Trial. J Pain Symptom Manage. 2016 Oct;52(4):459-468.e1. doi: 10.1016/j.jpainsymman.2016.05.013. Epub 2016 Jul 9.