Advanced CancersPhase 1/2NCT01515566
Breakthrough Dyspnea Fentanyl Study in Cancer Patients
A Phase 1/2 study testing Fentanyl, Walking Tests and Questionnaires in people with Advanced Cancers and Dyspnea, 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 given under the skin can reduce shortness of breath in cancer patients. Researchers also want to learn if it 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, Dyspnea
- What is being tested?
- Fentanyl, Walking Tests and Questionnaires
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Apr 2013
- Phase
- Phase 1/2
- 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
- Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level >=3/10 on the numeric rating scale
- Outpatient or inpatient at MD Anderson Cancer Center seen by the Supportive Care or Rehabilitation Service
- Able to communicate in English or Spanish
- Ambulatory and able to walk with or without walking aid
- On strong opioids with morphine equivalent daily dose of 30-580 mg, with stable (i.e. +/- 30%) regular dose over the last 24 hours
- Karnofsky performance status >=50%
- Age 18 or older
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 9Show fewer
- History of active substance abuse within the past 12 months
- History of allergy to fentanyl
- Unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Prophylactic Subcutaneous Fentanyl on Exercise-Induced Breakthrough Dyspnea in Cancer Patients: A Preliminary Double-Blind, Randomized Controlled Trial
The goal of this clinical research study is to learn if fentanyl given under the skin can reduce shortness of breath in cancer patients. Researchers also want to learn if it 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. It is believed to help patients with their shortness of breath as well.
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.
Study Drug/Placebo Administration:
Before you receive the study drug/placebo, you will walk back and forth in an indoor corridor 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 up to 1 hour). During this time, the study drug/placebo will be prepared.
You will then be given a study drug/placebo shot under the skin in your arms or legs. You will then wait for another 15 minutes and repeat the walking test.
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 also complete 2 walking tests. Before the walk tests, you will complete 2 questionnaires. One (1) of them asks 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.
Before and after each walk test, the study staff will record your heart rate, breathing rate, and the level of air breathed out using a measuring device that will be clipped onto your finger. The study staff will also ask you questions about how hard it is to catch your breath and your level of tiredness.
During each walk test, you will be asked about 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 walk test, 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 2 walk tests, you may be asked how hard it is to catch your breath several times.
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, 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 100 minutes.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. It's 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.
- Conditions
- Advanced Cancers, Dyspnea
- Being tested
- Fentanyl, Placebo, Walking Tests, Questionnaires
- Keywords
- Advanced Cancer, Dyspnea, Exercise-induced breakthrough dyspnea, Shortness of breath, Fentanyl, Sublimaze, Placebo, Normal saline, NS, Questionnaires, Surveys, Walk test
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Sublimaze
Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before 6 minute walk test.
PlaceboOther
Normal saline 0.9% preservative free SQ 15 minutes before walk test.
Walking TestsOther
6 minute walk test at baseline and 15 minutes after Fentanyl or Placebo.
QuestionnairesBehavioural
Also called Surveys
Questionnaires completed at baseline (two) and after study visit (one) taking about 5 ot 10 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Experimental | Fentanyl subcutaneously (SQ) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test, and 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl. Two (2) Questionnaires completed at baseline taking about 10 minutes to complete, and one completed after study visit taking about 5 minutes to complete. Receives: Drug: Fentanyl; Other: Walking Tests; Behavioral: Questionnaires |
| Placebo | Active comparator | Normal saline 0.9% preservative free SQ 15 minutes before walk test, and 6 minute walk test at baseline and 15 minutes after Placebo. Two (2) Questionnaires completed at baseline taking about 10 minutes to complete, and one completed after study visit taking about 5 minutes to complete. Receives: Other: Placebo; Other: Walking Tests; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate
Retention rate is defined as the percentage of subjects able to complete the study.
Measured: Baseline to study completion, up to 100 minutes.
Secondary outcomes (2)
Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea
Participants receive either Fentanyl subcutaneous (SQ) 15 minutes before walking test, or Placebo (SQ) 15 minutes before walking test. During the study, trained research staff perform study assessments and monitor participant carefully throughout the study period. Six-minute walk tests were carried out following guidelines from the American Thoracic Society. The intensity of dyspnea at 0, 1, 2, 3, 4, 5 and 6 minute of each walk test were assessed using a validated numeric rating scale (NRS) ranging from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath") and every 5 minutes during the rest period.
Measured: Baseline to 100 minutes for study participation.
Effect of Fentanyl on Walk Distance
Ambulatory patients with breakthrough dyspnea performed a baseline 6 minute walk test (6MWT), and then received either subcutaneous fentanyl or placebo 15 minutes before a second 6MWT. The change in walk distance was documented between the first and second 6MWT.
Measured: Baseline 6 minute walk test (6MWT) to second 6MWT, up to 100 minutes for study participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hui, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515566
- Sponsor's protocol ID
- 2011-1007
- Status last verified
- Aug 2014
- First submitted
- 13 Jan 2012
- Last updated
- 22 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hui D, Xu A, Frisbee-Hume S, Chisholm G, Morgado M, Reddy S, Bruera E. Effects of prophylactic subcutaneous fentanyl on exercise-induced breakthrough dyspnea in cancer patients: a preliminary double-blind, randomized, controlled trial. J Pain Symptom Manage. 2014 Feb;47(2):209-17. doi: 10.1016/j.jpainsymman.2013.03.017. Epub 2013 Jul 3.
PubMed 23830530
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prophylactic Subcutaneous Fentanyl on Exercise-Induced Breakthrough Dyspnea in Cancer Patients: A Preliminary Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01515566
- Acronym / sponsor ID
- 2011-1007
- Conditions
- Advanced Cancers, Dyspnea
- Keywords
- Advanced Cancer, Dyspnea, Exercise-induced breakthrough dyspnea, Shortness of breath, Fentanyl, Sublimaze, Placebo, Normal saline
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Posted 22 Aug 2014
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 given under the skin can reduce shortness of breath in cancer patients. Researchers also want to learn if it 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. It is believed to help patients with their shortness of breath as well.
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.
Study Drug/Placebo Administration:
Before you receive the study drug/placebo, you will walk back and forth in an indoor corridor 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 up to 1 hour). During this time, the study drug/placebo will be prepared.
You will then be given a study drug/placebo shot under the skin in your arms or legs. You will then wait for another 15 minutes and repeat the walking test.
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 also complete 2 walking tests. Before the walk tests, you will complete 2 questionnaires. One (1) of them asks 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.
Before and after each walk test, the study staff will record your heart rate, breathing rate, and the level of air breathed out using a measuring device that will be clipped onto your finger. The study staff will also ask you questions about how hard it is to catch your breath and your level of tiredness.
During each walk test, you will be asked about 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 walk test, 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 2 walk tests, you may be asked how hard it is to catch your breath several times.
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, 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 100 minutes.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. It's 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Experimental | Drug: Fentanyl, Other: Walking Tests, Behavioral: QuestionnairesFentanyl subcutaneously (SQ) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test, and 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl. Two (2) Questionnaires completed at baseline taking about 10 minutes to complete, and one completed after study visit taking about 5 minutes to complete. |
| Placebo | Active comparator | Other: Placebo, Other: Walking Tests, Behavioral: QuestionnairesNormal saline 0.9% preservative free SQ 15 minutes before walk test, and 6 minute walk test at baseline and 15 minutes after Placebo. Two (2) Questionnaires completed at baseline taking about 10 minutes to complete, and one completed after study visit taking about 5 minutes to complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of cancer
- Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level >=3/10 on the numeric rating scale
- Outpatient or inpatient at MD Anderson Cancer Center seen by the Supportive Care or Rehabilitation Service
- Able to communicate in English or Spanish
- Ambulatory and able to walk with or without walking aid
Key exclusion criteria (9 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 |
|---|---|---|
| FentanylAlso: SublimazeFentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before 6 minute walk test. | Drug | Fentanyl |
| PlaceboNormal saline 0.9% preservative free SQ 15 minutes before walk test. | Other | Placebo |
| Walking Tests6 minute walk test at baseline and 15 minutes after Fentanyl or Placebo. | Other | Fentanyl, Placebo |
| QuestionnairesAlso: SurveysQuestionnaires completed at baseline (two) and after study visit (one) taking about 5 ot 10 minutes to complete. | Behavioural | Fentanyl, Placebo |
Primary outcome
Retention Rate
Time frame: Baseline to study completion, up to 100 minutes.
Retention rate is defined as the percentage of subjects able to complete the study.
2 secondary outcomes
Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea
Time frame: Baseline to 100 minutes for study participation.
Effect of Fentanyl on Walk Distance
Time frame: Baseline 6 minute walk test (6MWT) to second 6MWT, up to 100 minutes for study participation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23830530Hui D, Xu A, Frisbee-Hume S, Chisholm G, Morgado M, Reddy S, Bruera E. Effects of prophylactic subcutaneous fentanyl on exercise-induced breakthrough dyspnea in cancer patients: a preliminary double-blind, randomized, controlled trial. J Pain Symptom Manage. 2014 Feb;47(2):209-17. doi: 10.1016/j.jpainsymman.2013.03.017. Epub 2013 Jul 3.
- UT 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
UT MD 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 1/2 study testing Fentanyl, Walking Tests and Questionnaires in people with Advanced Cancers and Dyspnea, 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 8 inclusion and 9 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 22 Aug 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 22 Aug 2014). 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?
Retention Rate (time frame: Baseline to study completion, up to 100 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01515566, which also lists 1 linked publication.
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 22 Aug 2014.