A Phase 2 interventional study of Fentanyl Buccal Tablet and Placebo Buccal Tablet 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 2020-09-16.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The goal of this clinical research study is to learn if fentanyl can change perception of shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function. In this study, fentanyl will be compared to a placebo.
Fentanyl is commonly used for treatment of cancer pain.
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 either receive fentanyl or placebo. You will have an equal chance of being assigned to either group. Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Visit:
During your study visit, the study staff will collect information from your medical record about your age, sex, race, disease type, how well you are able to perform the normal activities of daily living, any drugs you are taking, and possible causes of shortness of breath.
You will complete 2 questionnaires. One (1) of them will have questions about any breathing symptoms you may be having, and the other asks about any other symptoms you may be having. It should take about 10 minutes to complete these questionnaires.
The study staff will then record your vital signs (heart rate, breathing rate, and the level of air breathed out using a measuring device that will be clipped onto your finger). You will also be asked how hard it is to catch your breath and to rate your level of tiredness.
You will then walk back and forth in an indoor corridor for up to 6 minutes. This is called a walk test. You may slow down, stop, and rest at any time you need to.
After that, you will sit down and rest for up to 1 hour. During this time, the study drug/placebo will be prepared and you may be asked several times how hard it is to catch your breath.
You will then be given a study drug/placebo tablet to put it in between your upper gum and cheek. You will then wait for another 30 minutes, be asked about any side effects you may be having, and repeat the walking test. Then the study staff will ask you again about any side effects you may be having, your level of tiredness, and how hard it is to catch your breath. Your vital signs will also be measured.
During each walk test, you will be asked 6 times how hard it is to catch your breath. How often you stopped and for how long will be recorded. The total distance you walked will also be recorded.
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 fill out 1 questionnaire that asks if you think the study drug/placebo is helping you, how satisfied you are with the study, and which treatment you think you received. It should take about 5 minutes to complete the questionnaire.
Length of Study:
Your active participation in this study is over after you complete the last questionnaire. You will be taken off study if intolerable side effects occur or if you are unable to follow study directions.
Follow-Up:
Thirty (30) days after your study visit you will be called by the study staff and asked how you are feeling and about any side effects you may be having. This call should last about 10 minutes.
This is an investigational study. Fentanyl is FDA approved and commercially available for the treatment of pain. Its use to control shortness of breath is investigational.
Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.
This study's enrollment of 36 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:
After a six minute walk test, participant will sit down and rest for up to 1 hour. They will then be given a Fentanyl tablet to put in between upper gum and cheek. Study physician will determine the morphine equivalent daily dose (MEDD) in real time using standardized equianalgesic ratios. Based on clinical practice and similarly to the dose used for breakthrough pain, an FBT dose equivalent to 20-50% of the MEDD used. After 30 minutes, participant asked about any side effects they may be having, and repeat the walking test. During each walk test, participant asked 6 times how hard it is to catch their breath. The total distance walked will also be recorded. Completion of two questionnaires at beginning of study visit. It should take about 10 minutes to complete. At the end of study visit, completion of last questionnaire. It should take about 5 minutes to complete the questionnaire.
Drug: Fentanyl Buccal Tablet · Behavioral: Questionnaires
After a six minute walk test, participant will sit down and rest for up to 1 hour. They will then be given a Placebo tablet to put in between upper gum and cheek. After 30 minutes, participant asked about any side effects they may be having, and repeat the walking test. During each walk test, participant asked 6 times how hard it is to catch their breath. The total distance walked will also be recorded. Completion of two questionnaires at beginning of study visit. It should take about 10 minutes to complete. At the end of study visit, completion of last questionnaire. It should take about 5 minutes to complete the questionnaire.
Other: Placebo Buccal Tablet · Behavioral: Questionnaires
Fentanyl buccal tablet given to put in between upper gum and cheek one hour after a six minute walk test.
Placebo buccal tablet given to put in between upper gum and cheek one hour after a six minute walk test.
Completion of two questionnaires at beginning of study visit. It should take about 10 minutes to complete. At the end of study visit, completion of last questionnaire. It should take about 5 minutes to complete the questionnaire.
Also known as: Surveys
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 between the baseline and second 6 minute walk test. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.
Time frame: Baseline to 30 minutes
Dyspnea Borg Scale
Assessed 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.
Time frame: Baseline to 30 minutes
Walk Distance at 6 Minutes
Measured the mean difference between the baseline walk test and second 6 minute walk test.
Time frame: Baseline to 30 minutes
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.
| Milestone | Intervention Group (Fentanyl Buccal Tablet) | Controlled Group (Placebo) |
|---|---|---|
| Started | 11 | 11 |
| Completed | 9 | 11 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
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.
| score on a scale | Intervention Group (Fentanyl Buccal Tablet) | Controlled Group (Placebo) |
|---|---|---|
| Dyspnea Numeric Rating Scale | -2.4 (-3.5 to -1.3) | -1.1 (-2.5 to 0.2) |
Assessed 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.
| score on a scale | Intervention Group (Fentanyl Buccal Tablet) | Controlled Group (Placebo) |
|---|---|---|
| Dyspnea Borg Scale | -1.6 (-2.9 to -0.3) | -0.5 (-1.9 to 0.8) |
Measured the mean difference between the baseline walk test and second 6 minute walk test.
| meters | Intervention Group (Fentanyl Buccal Tablet) | Controlled Group (Placebo) |
|---|---|---|
| Walk Distance at 6 Minutes | -1 (-22.3 to 20.3) | 6.7 (-3.4 to 16.9) |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group (Fentanyl Buccal Tablet) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Controlled Group (Placebo) | 0/11 (0%) | 0/11 (0%) | 2/11 (18.2%) |
| Event | Intervention Group (Fentanyl Buccal Tablet) | Controlled Group (Placebo) |
|---|---|---|
| DizzyNervous system disorders | 0/9 | 2/11 |
| DrowsyNervous system disorders | 0/9 | 2/11 |
| ItchinessSkin and subcutaneous tissue disorders | 0/9 | 2/11 |
The data provided is for the 20 participants that completed the study.
| Age, Continuous(years) | Intervention Group (Fentanyl Buccal Tablet) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| Mean | 52 (31 to 67) | 57 (45 to 72) | 55 (31 to 72) |
| Sex: Female, Male(Participants) | Intervention Group (Fentanyl Buccal Tablet) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 3 | 5 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group (Fentanyl Buccal Tablet) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 9 | 9 | 18 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention Group (Fentanyl Buccal Tablet) | 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 | 2 | 3 | 5 |
| White | 7 | 8 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Intervention Group (Fentanyl Buccal Tablet) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| United States | 9 | 11 | 20 |
| Education(Participants) | Intervention Group (Fentanyl Buccal Tablet) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| High School or less | 7 | 9 | 16 |
| College and above | 2 | 2 | 4 |
| Cancer Stage(Participants) | Intervention Group (Fentanyl Buccal Tablet) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| Metastatic Stage | 9 | 10 | 19 |
| Locally Advanced | 0 | 1 | 1 |
| Cancer Type(Participants) | Intervention Group (Fentanyl Buccal Tablet) | Controlled Group (Placebo) | Total |
|---|---|---|---|
| Lung Cancer | 3 | 5 | 8 |
| Breast Cancer | 1 | 2 | 3 |
| Gastrointestinal Cancer | 2 | 1 | 3 |
| Genitourinary Cancer | 2 | 1 | 3 |
| Other | 1 | 1 | 2 |
| Gynecologic Cancer | 0 | 1 | 1 |
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M.D. Anderson Cancer Center