cancer and malignant neoplasms with an opioid medication around the clock. C00-C97 R06.0
Conditions
Interventions
Group 1: Titrationphase: 2 x (1 to 2) days (due to the design 2x 2 crossover)
Fentanyl buccal tablets FBT at a dose of 100µg- 600µg
Trade Name: Effentora tablet
Oral intake: as soon as a breath epis
Sponsors
Universitätsklinikum Koeln
Zentrum für Palliativmedizin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with cancer suffering from episodes of dyspnoea (ED), inpatients only 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
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 (except sufficiently palliated chronic malignant bowl obstruction) 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 for breakthrough cancer pain (BTCP) during the trial 9. The use of a monoamine oxidase inhibitors within the previous 14 days 10. Treatment with any other investigational drugs within the previous 10 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
|---|---|
| • 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 target variable: • Time to onset of meaningful dyspnoea relief Secondary target variables: • Dyspnoea intensity • Coping capacity, unpleasantness, impact of ED • Use of rescue medication • Patient’s & investigator’s satisfaction of dyspnoea relief and route of application (ease of administration) and preferences of study drugs Feasibility and other variables: • Feasibility of study procedures during titration phase (TPh) and efficacy phase (EPh) • Feasibility of recruitment • Feasibility of outcome measurement tools • Feasibility of rescue procedures • Characteristics of ED and breathlessness in general Safety variables: • Incidence and nature of adverse events (AE) and serious adverse Events (SAEs) • Vigilance, respiratory rate (rr), oxygen saturation (oxy sat) • Blood pressure (BP), heart rate (HR), Karnofsky Perfomance Status (KPS) | — |
Countries
Germany
Contacts
Public ContactMaren Piel
Uniklinik Köln Zentrum für Palliativmedizin
Outcome results
None listed