A Phase 2 interventional study of Fentanyl and Immediate release morphine in Cancer and Dyspnea, Paroxysmal, sponsored by University of Cologne. Completed at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-19.
Sponsored by University of Cologne · Phase 2, Interventional, and Treatment
"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.
656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.
This study's enrollment of 10 is below the median of 48 across 430 interventional studies indexed under Dyspnea.
Browse Dyspnea studies →University of Cologne is the lead sponsor of 199 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Fentanyl buccal tablet Dosage: 100µg - 600 µg Fentanyl (to be determined by titration) Administration: buccal administration (tablet)
Drug: Fentanyl
Immediate release morphine, solution Dosage: Start with a minimum of 5mg (to be determined by titration)
Drug: Immediate release morphine
Also known as: Fentanyl buccal tablet, Fentanyl citrate
Also known as: Morphine Solution
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)
Time frame: minutes (by stop watch) from drug application of FBT/IRM up to breathlessness relief
Breathlessness intensity
Breathlessness intensity measured by NRS (range 0-10)
Time frame: at 0, 3, 5, 10, 15, 20, 30, 45 and 60 minutes after application of FBT/IRM
Numbers of rescue medication doses
If adequate breathlessness relief was not reached after 30 min, the patient could use his standard rescue medication.
Time frame: Numbers of rescue medication doses through study completion, assessed at day 10 (final visit)
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).
Time frame: through study completion, day 10 (e.g. final visit)
Preferences of study drugs
FBT or IRM or both/none
Time frame: through study completion, day 10 (e.g. final visit)
Number of (serious) adverse events (AE/SAE; Safety of FBNT/IRM)
Counts of adverse events
Time frame: through study completion, day 10 (e.g. final visit)
Severity of AE/SAE (Safety of FBNT/IRM)
CTCAE tool v4.03 (National Cancer Institute Common Terminology Criteria)
Time frame: through study completion, day 10 (e.g. final visit)
Oxygen saturation (Safety of FBNT/IRM)
finger clip pulse oximetry (Contec Medical Systems Co., China)
Time frame: through study completion, day 10 (e.g. final visit)
Patient's vigilance (Safety of FBNT/IRM)
Glasgow Coma Scale (GCS)
Time frame: through study completion, day 10 (e.g. final visit)
Respiratory rate (Safety of FBNT/IRM)
breaths per minute
Time frame: through study completion, day 10 (e.g. final visit)
Enrollment rate (Feasibility of study procedures)
Ratio of patients screened to patient with informed consent
Time frame: day 10 (e.g. final visit)
Completion rate (Feasibility of study procedure)
Ratio of patients that were randomly assigned to the experimental vs active comparator arm to patients that completed the study
Time frame: day 10 (e.g. final visit)
Drop outs (Feasibility of study procedures)
Counts of drop out per visit (TPh+EPh)
Time frame: day 10 (e.g. final visit)
Reasons for rejection of study participation of screened patient (Feasibility of study procedures)
List of reasons/ free text responses
Time frame: day 10 (e.g. final visit)
Acceptability of study procedures
closed questions: 4-point verbal rating scale between 0=poor/unsatisfied and 4=excellent/very satisfied, and yes/no; reports by patients, investigators and clinical team
Time frame: day 10 (e.g. final visit)
Acceptability of measurement tools
closed questions: 4-point verbal rating scale between 0=poor/unsatisfied and 4=excellent/very satisfied, and yes/no; reports by patients, investigators and clinical team
Time frame: day 10 (e.g. final visit)
Acceptability of rescue procedures
closed questions: 4-point verbal rating scale between 0=poor/unsatisfied and 4=excellent/very satisfied, and yes/no; reports by patients, investigators and clinical team
Time frame: day 10 (e.g. final visit)
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University of Cologne