A Phase 2 interventional study of Fentanyl Pectin Nasal Spray and Placebo Nasal Spray in Advanced Cancers, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-08.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Supportive care
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.
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.
656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.
This study's enrollment of 35 is below the median of 48 across 430 interventional studies indexed under Dyspnea.
Browse Dyspnea studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD). FPNS administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test. Walk test administered before first dose of FPNS. Participant will rest for 30 minutes after walk test. FPNS administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. FPNS administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes. Questionnaires completed at baseline, before each walk test, and at end of final walk test. Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.
Drug: Fentanyl Pectin Nasal Spray · Other: Walk Test · Behavioral: Questionnaires · Behavioral: Mental Ability Tests
Placebo nasal spray administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test. Walk test administered before first dose of placebo nasal spray. Participant will rest for 30 minutes after walk test. Placebo nasal spray administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. Placebo nasal spray administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes. Questionnaires completed at baseline, before each walk test, and at end of final walk test. Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.
Drug: Placebo Nasal Spray · Other: Walk Test · Behavioral: Questionnaires · Behavioral: Mental Ability Tests
Fentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.
Placebo nasal spray administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.
Walk test administered before first dose of drug/placebo nasal spray. Participant will rest for 30 minutes after walk test. Drug/placebo nasal spray administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. Drug/placebo nasal spray administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes.
Questionnaires completed at baseline, before each walk test, and at end of final walk test.
Also known as: Surveys
Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.
Dyspnea Numeric Rating Scale
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 of dyspnea numeric rating scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.
Time frame: 1.5 to 2 hours on a Single visit
Dyspnea Borg Scale
Assessed dyspnea using the modified Dyspnea Borg Scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference of modified Dyspnea Borg scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests.
Time frame: 1.5 to 2 hours on a Single visit
Walk Distance at 6 Minutes
Compared the mean difference of distance between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests.
Time frame: 1.5 to 2 hours on a Single visit
Adult participants (age\>18) with an active diagnosis of cancer were recruited between 6/2013 and 3/2015 from the Supportive Care Center outpatient clinic of MD Anderson Cancer Center who satisfied the inclusion and exclusion criteria.
| Milestone | Intervention Group (Fentanyl Pectin Nasal Spray) | Controlled Group (Placebo) |
|---|---|---|
| Started | 19 | 16 |
| Received allocated medication | 12 | 12 |
| Completed study with correct dose | 10 | 9 |
| Completed study with incorrect dose | 2 | 3 |
| Completed | 12 | 12 |
| Not completed | 7 | 4 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Declining performance status | 2 | 1 |
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 of dyspnea numeric rating scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.
| score on a scale | Intervention Group (Fentanyl Pectin Nasal Spray) | Controlled Group (Placebo) |
|---|---|---|
| Mean difference between 1st and 2nd walk tests | -2.0 (-3.5 to -0.6) | -1.7 (-3.3 to -0.1) |
| Mean difference between 1st and 3rd walk tests | -2.3 (-4.0 to -0.7) | -2.5 (-4.2 to -0.9) |
Assessed dyspnea using the modified Dyspnea Borg Scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference of modified Dyspnea Borg scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests.
| score on a scale | Intervention Group (Fentanyl Pectin Nasal Spray) | Controlled Group (Placebo) |
|---|---|---|
| Mean difference between 1st and 2nd walk tests | -1.8 (-3.1 to -0.4) | -1.7 (-3.3 to -0.1) |
| Mean difference between 1st and 3rd walk tests | -1.7 (-3.5 to 0) | -2.4 (-4.2 to -0.6) |
Compared the mean difference of distance between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests.
| meters | Interventional Group (Fentanyl Pectin Nasal Spray) | Control Group (Placebo) |
|---|---|---|
| Mean difference between 1st and 2nd walk tests | 23.8 (1.3 to 46.2) | 16.3 (-8.6 to 41.3) |
| Mean difference between 1st and 3rd walk tests | 23.3 (-1.7 to 48.2) | 14.6 (-11.0 to 40.3) |
Collected over Baseline, up to 2 hours in one single visit. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interventional (Fentanyl Pectin Nasal Spray) Second Walk Test | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) |
| Control (Placebo), Second Walk Test | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) |
| Interventional (Fentanyl Pectin Nasal Spray),Third Walk Test | 0/12 (0%) | 0/12 (0%) | 5/12 (41.7%) |
| Control (Placebo), Third Walk Test | 0/12 (0%) | 0/12 (0%) | 5/12 (41.7%) |
| Event | Interventional (Fentanyl Pectin Nasal Spray) Second Walk Test | Control (Placebo), Second Walk Test | Interventional (Fentanyl Pectin Nasal Spray),Third Walk Test | Control (Placebo), Third Walk Test |
|---|---|---|---|---|
| DizzinessNervous system disorders | 2/12 | 2/12 | 5/12 | 1/12 |
| DrowsinessNervous system disorders | 1/12 | 2/12 | 1/12 | 5/12 |
| NauseaGastrointestinal disorders | 0/12 | 0/12 | 2/12 | 0/12 |
| Stuffy NoseRespiratory, thoracic and mediastinal disorders | 0/12 | 2/12 | 0/12 | 0/12 |
| Nose DrynessRespiratory, thoracic and mediastinal disorders | 0/12 | 2/12 | 0/12 | 2/12 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/12 | 0/12 | 0/12 | 1/12 |
| Sore throatRespiratory, thoracic and mediastinal disorders | 0/12 | 1/12 | 0/12 | 0/12 |
Intention to treat analysis participants data
| Age, Continuous(Years) | Intervention Group (Fentanyl Pectin Nasal Spray) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| Mean | 51.5 (44.7 to 58.3) | 53.3 (45.0 to 61.6) | 52.4 (47.5 to 57.4) |
| Sex: Female, Male(Participants) | Intervention Group (Fentanyl Pectin Nasal Spray) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| Female | 9 | 4 | 13 |
| Male | 3 | 8 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group (Fentanyl Pectin Nasal Spray) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 11 | 10 | 21 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention Group (Fentanyl Pectin Nasal Spray) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 2 | 5 |
| White | 9 | 10 | 19 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Intervention Group (Fentanyl Pectin Nasal Spray) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
| Education(Participants) | Intervention Group (Fentanyl Pectin Nasal Spray) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| High School or less | 4 | 2 | 6 |
| College | 8 | 7 | 15 |
| Advanced Degree | 0 | 3 | 3 |
| Cancer Type(Participants) | Intervention Group (Fentanyl Pectin Nasal Spray) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| GastroIntestinal Cancer | 2 | 4 | 6 |
| Breast Cancer | 3 | 2 | 5 |
| Lung Cancer | 1 | 2 | 3 |
| Genitourinary Cancer | 2 | 0 | 2 |
| Gynecologic Cancer | 2 | 0 | 2 |
| Hematologic | 0 | 2 | 2 |
| Others | 2 | 2 | 4 |
| Cancer Stage(Participants) | Intervention Group (Fentanyl Pectin Nasal Spray) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| Metastatic Stage | 8 | 10 | 18 |
| Localized/Locally advanced | 4 | 2 | 6 |
1 further baseline measures are reported on the registry.
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M.D. Anderson Cancer Center