Advanced CancersPhase 2NCT01856114
Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea
A Phase 2 study testing Fentanyl Buccal Tablet and Questionnaires in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Fentanyl Buccal Tablet and Questionnaires
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2014to 4 Dec 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cancer with evidence of active disease
- Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level >/=3/10 on the numeric rating scale
- Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service, Thoracic Medical Oncology or Cardiopulmonary Center
- Ambulatory and able to walk with or without walking aid
- On strong opioids with morphine equivalent daily dose of 60-130 mg for at least one week, with stable (i.e. +/- 30%) regular dose over the last 24 hours
- Karnofsky performance status >/=50%
Show all 9Show fewer
- Age 18 or older
- Able to complete study assessments
- Must speak and understand English.
Who cannot join
- Dyspnea at rest >/=7/10 at the time of enrollment
- Supplemental oxygen requirement >6 L per minute
- Delirium (i.e. Memorial delirium rating scale >13)
- History of unstable angina or myocardial infarction 1 month prior to study enrollment
- Resting heart rate >120 at the time of study enrollment
- Systolic pressure >180 mmHg or diastolic pressure >100 mmHg at the time of study enrollment
Show all 13Show fewer
- History of active opioid abuse within the past 12 months
- History of allergy to fentanyl
- Severe anemia (Hb <7g/L) if documented in the last month and not corrected prior to study enrollment*
- Bilirubin >5X Upper limit of normal if documented in the last month and not lowered to <5x normal prior to study enrollment*
- Diagnosis of acute pulmonary embolism within past 2 weeks
- Diagnosis of pulmonary hypertension
- Unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Preliminary Study of Prophylactic Fentanyl Buccal Tablets (FBT) for Exercise Induced Breakthrough Dyspnea
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.
Read the 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 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.
- Conditions
- Advanced Cancers
- Being tested
- Fentanyl Buccal Tablet, Placebo Buccal Tablet, Questionnaires
- Keywords
- Advanced Cancers, Cancer with evidence of active disease, Exercise induced breakthrough dyspnea, Shortness of breath, Fentanyl Buccal Tablets, FBT, Placebo, Walk tests, Questionnaires, Surveys
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl Buccal TabletDrug
Fentanyl buccal tablet given to put in between upper gum and cheek one hour after a six minute walk test.
Placebo Buccal TabletOther
Placebo buccal tablet given to put in between upper gum and cheek one hour after a six minute walk test.
QuestionnairesBehavioural
Also called Surveys
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.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl Buccal Tablet | Experimental | 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. Receives: Drug: Fentanyl Buccal Tablet; Behavioral: Questionnaires |
| Placebo Buccal Tablet | Placebo comparator | 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. Receives: Other: Placebo Buccal Tablet; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 30 minutes
Secondary outcomes (2)
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.
Measured: Baseline to 30 minutes
Walk Distance at 6 Minutes
Measured the mean difference between the baseline walk test and second 6 minute walk test.
Measured: Baseline to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study start27 May 2014
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
- Investigators
- David Hui, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856114
- Sponsor's protocol ID
- 2013-0043
- Other IDs
- NCI-2014-01033
- Status last verified
- Sep 2020
- First submitted
- 14 May 2013
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study of Prophylactic Fentanyl Buccal Tablets (FBT) for Exercise Induced Breakthrough Dyspnea
- ClinicalTrials.gov ID
- NCT01856114
- Acronym / sponsor ID
- 2013-0043
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancers, Cancer with evidence of active disease, Exercise induced breakthrough dyspnea, Shortness of breath, Fentanyl Buccal Tablets, FBT, Placebo, Walk tests
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 27 May 2014 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl Buccal Tablet | Experimental | Drug: Fentanyl Buccal Tablet, Behavioral: QuestionnairesAfter 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. |
| Placebo Buccal Tablet | Placebo comparator | Other: Placebo Buccal Tablet, Behavioral: QuestionnairesAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of cancer with evidence of active disease
- Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level >/=3/10 on the numeric rating scale
- Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service, Thoracic Medical Oncology or Cardiopulmonary Center
- Ambulatory and able to walk with or without walking aid
- On strong opioids with morphine equivalent daily dose of 60-130 mg for at least one week, with stable (i.e. +/- 30%) regular dose over the last 24 hours
Key exclusion criteria (13 listed)
- Dyspnea at rest >/=7/10 at the time of enrollment
- Supplemental oxygen requirement >6 L per minute
- Delirium (i.e. Memorial delirium rating scale >13)
- History of unstable angina or myocardial infarction 1 month prior to study enrollment
- Resting heart rate >120 at the time of study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl Buccal TabletFentanyl buccal tablet given to put in between upper gum and cheek one hour after a six minute walk test. | Drug | Fentanyl Buccal Tablet |
| Placebo Buccal TabletPlacebo buccal tablet given to put in between upper gum and cheek one hour after a six minute walk test. | Other | Placebo Buccal Tablet |
| QuestionnairesAlso: SurveysCompletion 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. | Behavioural | Fentanyl Buccal Tablet, Placebo Buccal Tablet |
Primary outcome
Dyspnea Numeric Rating Scale
Time frame: Baseline to 30 minutes
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.
2 secondary outcomes
Dyspnea Borg Scale
Time frame: Baseline to 30 minutes
Walk Distance at 6 Minutes
Time frame: Baseline to 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hui, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fentanyl Buccal Tablet and Questionnaires in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea Numeric Rating Scale (time frame: Baseline to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.