Patients with cancer suffering from episodes of dyspnoea (ED)
Conditions
Interventions
Trade Name: Effentora 100µg
Product Name: Effentora
Pharmaceutical Form: Buccal tablet
INN or Proposed INN: Effentora 100 micrograms buccal tablets
Other descriptive name: FENTANYL CITRATE
Concentrati
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Principal inclusion criteria: 1. Histologically or cytologically proven cancer of any entity which is non-curable as judged by the referring physician or investigator 2. To be an inpatient during the study 3. Refractory dyspnoea – this study applies only to ‘refractory dyspnoea’ and is defined: a patient is still dyspnoic although the underlying disease (e.g. lung cancer) or cause of dyspnoea (e.g. pleural effusion) is treated optimal as judged by the referring physician or investigator 4. History of recurrent ED - ED is defined as an increase in dyspnoea occurring intermittently in patients with or without underlying continuous dyspnoea 5. Peak intensity of ED = 3 (NRS, 0-10) 6. 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 7. Life expectancy of at least one month as judged by the referring physician or investigator Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Principal exclusion criteria: 1. Uncontrolled dyspnoea (i.e. rapidly worsening dyspnoea requiring urgent medical or technical intervention) 2. Uncotrolled performance status (i.e. rapid deterioriation of performance status) 3. Consideration of any reason by the referring therapeutic team that the patient is not an appropriate participant of a clinical trial 4. Respiratory depression or preconditions with risk of respiratory depression 5. Acute abdomen or ileus or any situation that drug resoprtion is not possible 6. Renal dysfunction with creatinine clearance (eGFR) calculated as less than 25 ml/minute 7. Medical history of severe hepatic impairment 8. The use of fentanyl transmucosal products during the trial 9. The use of a monoamine oxidase inhibitors, SSRIs or SNRIs within the previous 14 days 10. Treatment with any other investigational drugs within the previous 10 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To assess safety of opioids in patients with dyspnoea • To determine relative clinical efficacy of two different opioids (FBT and IRM) for the relief of dyspnoea intensity • To determine relative clinical efficacy of two different opioids (FBT and IRM) for a better coping capacity, unpleasantness and impact of ED • To compare the use of rescue medication between two different opioids (FBT and IRM) • To compare patient’s & investigator’s satisfaction of dyspnoea relief and route of application (ease of administration) and preference between two different opioids (FBT and IRM) • To evaluate the feasibility of titration process, recruitment, study procedures, rescue procedures, and outcome measures • To describe the characteristics of ED and dyspnoea in general ;Primary end point(s): • Time to onset of meaningful dyspnoea relief;Timepoint(s) of evaluation of this end point: Time to onset of meaningful dyspnoea relief will be measured by stopwatch: time in minutes between administration of study medication and onset of meaningful dyspnoea relief. ‘Meaningful dyspnoea relief’ is defined by the patient. ;Main Objective: To determine the time to onset of meaningful dyspnoea relief of fentanyl buccal tablet (FBT) in comparison to immediate-release morphine (IRM) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary target variables: 2. Dyspnoea intensity 3. Coping capacity, unpleasantness, impact of ED 4. Use of rescue medication 5. Patient’s & investigator’s satisfaction of dyspnoea relief and route of application (ease of administration) and preferences of study drugs Feasibility and additional variables: 6. Feasibility of study procedures during titration phase (TPh) and efficacy phase (EPh) 7. Feasibility of recruitment 8. Feasibility of outcome measurement tools 9. Feasibility of rescue procedures 10. Characteristics of ED and breathlessness in general Safety variables: 11. Incidence and nature of adverse events (AE) and serious adverse events (SAEs) 12. Vigilance, respiratory rate (rr), oxygen saturation (oxy sat) 13. Blood pressure (BP), heart rate (HR), Karnofsky Perfomance Status (KPS) ;Timepoint(s) of evaluation of this end point: Variable-2: at 0, 3, 5, 10, 15, 20, 30, 45 and 60 min after application of FBT/IRM Variables-3: baseline and final visit (coping + impact); Unpleasantness of ED will be measured before, 30 and 60 minutes after drug application Variable-4: twice daily Variable-5: All measures will be done at the final visit. Variable-6: final visit Variable-7: final visit Variable-8+9: final visit Variable-10: baseline + final visit Variable-11: follow-up Variable-12: twice daily Variable-13: baseline, final visit | — |
Countries
Germany
Contacts
Public ContactCatherine Vangierdegom
Clinical Trials Center Cologne, University of Cologne
Outcome results
None listed