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

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 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
• •4. History of recurrent episodic breathlessness - episodic breathlessness is defined as an increase in breathlessness occurring intermittently in patients with or without underlying continuous breathlessness
• •5. Peak intensity of episodic breathlessness ≥ 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