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CancerPhase 2EFFENDYSNCT04635852

Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Cancer Patients

A Phase 2 study testing Fentanyl and Immediate release morphine in people with Cancer and Dyspnea, Paroxysmal, run by University of Cologne at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

"Episodic breathlessness (or dyspnea) is one form of chronic refractory breathlessness characterized by a severe worsening of breathlessness intensity or unpleasantness beyond usual fluctuations in the patient's perception. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Dyspnea, Paroxysmal
What is being tested?
Fentanyl and Immediate release morphine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesGermany
Study dates
Mar 2013to Dec 2014
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Histologically or cytologically proven cancer of any entity which is non-curable as judged by the referring physician or investigator
  • To be an inpatient during the study
  • Refractory breathlessness - this study applies only to 'refractory breathlessness ' and is defined: a patient is still breathless although the underlying disease (e.g. lung cancer) or cause of breathlessness (e.g. pleural effusion) is treated optimal as judged by the referring physician or investigator
  • History of recurrent episodic breathlessness - episodic breathlessness is defined as an increase in breathlessness occurring intermittently in patients with or without underlying continuous breathlessness
  • Peak intensity of episodic breathlessness ≥ 3 (NRS, 0-10)
  • Opioid tolerance for at least one day - opioid tolerance is defined: patient who receive per day at least 30mg oral morphine, 15mg oral oxycodone, 4mg oral hydromorphone, 12µg/h transdermal fentanyl or an analgetic equivalent of a different opioid or a different routes of application
  • Life expectancy of at least one month as judged by the referring physician or investigator

Who cannot join

  • Uncontrolled breathlessness (i.e. rapidly worsening breathlessness requiring urgent medical or technical intervention)
  • Uncontrolled performance status (i.e. rapid deterioration of performance status)
  • Consideration of any reason by the referring therapeutic team that the patient is not an appropriate participant of a clinical trial
  • Respiratory depression or preconditions with risk of respiratory depression
  • Acute abdomen or ileus or any situation that drug resorption is not possible
  • Renal dysfunction with creatinine clearance (eGFR) calculated as less than 25 ml/minute
Show all 10Show fewer
  • Medical history of severe hepatic impairment
  • The use of fentanyl transmucosal products for breakthrough cancer pain (BTCP) during the trial
  • The use of a monoamine oxidase inhibitors within the previous 14 days
  • Treatment with any other investigational drugs within the previous 10 days

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Study Center Palliative Medicine

    Cologne, North Rhine-Westphalia, 50937

  • Hospital Essen- Mitte, Departement of Palliative Medicine

    Essen, North Rhine-Westphalia, 45136

  • University Hospital Göttingen Center of Palliative Medicine

    Göttingen, Hesse, 37075

Other trials in Germany

About this study

Official title: Effentora® for Dyspnoea - Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Cancer Patients: A Multicenter, Open Label, Randomized, Morphine-controlled, Crossover, Phase II-TRIAL

"Episodic breathlessness (or dyspnea) is one form of chronic refractory breathlessness characterized by a severe worsening of breathlessness intensity or unpleasantness beyond usual fluctuations in the patient's perception. Episodes are time-limited (seconds to hours) and occur intermittently, with or without underlying continuous breathlessness. Episodes may be predictable or unpredictable, depending on whether any trigger(s) can be identified. There is a range of known triggers which can interact (e.g. exertion, emotions, comorbidities or external environment). One episode can be caused by one or more triggers." ( definition by an international expert consensus [Simon et al. 2013]). Approximately half of patients with cancer complain about breathlessness with the highest prevalence in pulmonary malignancies. Episodic breathlessness is reported by 81% of breathless cancer patients with significant impairment on quality of life and limitations on activity. Although episodic breathlessness show some similar characteristics like episodes of pain (breakthrough cancer pain, BTCP; median duration 30minutes), they are often shorter: 91% last less than 20minutes (min). Other evidence supports these findings with duration between 2-15minutes which is a real challenge for the treatment of episodic breathlessness. In the majority of cases, episodic breathlessness occur 1-4 times per day and peak intensity is rated moderate or severe.

There is evidence for the effectiveness of opioids for the relief of chronic refractory breathlessness. There is no evaluated and proven standard treatment for the relief of episodic breathlessness at the moment but immediate-release morphine (IRM) as solution or tablet is most frequently used in clinical practice to treat episodic breathlessness. Time to onset of action of IRM is about 20-30min for pain. Fentanyl is a potent opioid and shows good evidence for the treatment of BTCP through its quick onset of action (5-15min) and short duration of action (50-60min). Because of its pharmacodynamic properties fentanyl might be appropriate and effective for the relief of episodic breathlessness. However, the efficacy of fentanyl for the relief of breathlessness and time to onset is unknown.

This pilot study aims to evaluate relative efficacy, feasibility and time to onset of two different opioids (fentanyl and morphine) in order to improve the management of episodic breathlessness.

Being tested
Fentanyl, Immediate release morphine
Medical subject headings
Neoplasms, Dyspnea, Paroxysmal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FentanylDrug

    Also called Fentanyl buccal tablet, Fentanyl citrate

  • Immediate release morphineDrug

    Also called Morphine Solution

Study groups in NCT04635852
Study groupRoleWhat they receive
FentanylExperimentalFentanyl buccal tablet Dosage: 100µg - 600 µg Fentanyl (to be determined by titration) Administration: buccal administration (tablet)
Receives: Drug: Fentanyl
Immediate release morphineActive comparatorImmediate release morphine, solution Dosage: Start with a minimum of 5mg (to be determined by titration)
Receives: Drug: Immediate release morphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to onset of meaningful breathlessness relief

    To determine the time to onset of meaningful breathlessness relief of fentanyl buccal tablet (FBT) in comparison to immediate-release morphine (IRM)

    Measured: minutes (by stop watch) from drug application of FBT/IRM up to breathlessness relief

Secondary outcomes (4)

  1. Breathlessness intensity

    Breathlessness intensity measured by NRS (range 0-10)

    Measured: at 0, 3, 5, 10, 15, 20, 30, 45 and 60 minutes after application of FBT/IRM

  2. Numbers of rescue medication doses

    If adequate breathlessness relief was not reached after 30 min, the patient could use his standard rescue medication.

    Measured: Numbers of rescue medication doses through study completion, assessed at day 10 (final visit)

  3. Patient's & investigator's satisfaction

    Patient's and investigator's satisfaction of breathlessness relief and route of application regarding ease of administration (4-point verbal rating scale: 0 = poor/unsatisfied and 4 = excellent/very satisfied).

    Measured: through study completion, day 10 (e.g. final visit)

  4. Preferences of study drugs

    FBT or IRM or both/none

    Measured: through study completion, day 10 (e.g. final visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2020
  2. Study startMar 2013
  3. Primary completionNov 2014
  4. Study completionDec 2014

Resources

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
Crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04635852
Sponsor's protocol ID
Uni-Koeln-1412
Other IDs
2011-005797-32, DRKS00004353
Acronym
EFFENDYS
Status last verified
Nov 2020
First submitted
10 Jan 2014
Last updated
19 Nov 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fentanyl and Immediate release morphine in people with Cancer and Dyspnea, Paroxysmal, run by University of Cologne at 3 sites in Germany.

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 7 inclusion and 10 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 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time to onset of meaningful breathlessness relief (time frame: minutes (by stop watch) from drug application of FBT/IRM up to breathlessness relief). 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 NCT04635852.

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 19 Nov 2020.

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