Nasal Fentanyl for Chronic Cancer Pain (NFCP-2)
Cancer, Pain
About this trial
This is an interventional treatment trial for Cancer focused on measuring fentanyl, administration, intranasal, morphine, patient satisfaction, patient preference
Eligibility Criteria
Inclusion Criteria:
- Cancer disease
- Adult (older than 18 years)
- Cancer-related pain > 4 on an 11 point Numerical Rating Scale (NRS)
- In the need of opioids (step II or III)
- Able to use nasal drugs.
- Life expectancy of > 6 months
- Karnofsky status > = 60
- Women of child bearing potential must use adequate contraception
- Informed consent given according to applicable requirements before any trial-related activities.
Exclusion Criteria:
- Use of opioids for moderate and severe pain
- History of substance abuse.*
- Pathological conditions of the nasal cavity as contraindication to nasal fentanyl
- Renal- or liver- failure, defined as creatinin > 150 and alanine-amino transferase (ALAT) > x 1.5 reference value
- Sleep apnoea syndrome, severe chronic obstructive lung disease or illnesses leading to severe respiratory depression.
- Psychiatric disease
- Neurological disease giving dizziness or sedation
- Cognitive impairment which makes the patient unable to complete questionnaires or not able to comply with the study procedures.
- Previous or ongoing facial radiotherapy
- Recurrent nose bleeding
- Known hypersensitivity to the active substances or excipients of the study drugs
- Pregnant or breastfeeding women
- Treated with monoamine oxidase (MAO) inhibitor within the last 14 days
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
intranasal fentanyl spray
slow release morphine
Fentanyl for nasal administration (NF), is supplied as sprays containing a phosphate buffered solution of fentanyl citrate. NF is available in three strengths: 0.5 mg/ml, 1 mg/ml and 2 mg/ml in multiple-dose sprays. The corresponding doses are 50, 100 and 200 µg/puff. NF is applied as one puff in one nostril. One puff defines and equals one dose. Applying a puff to each nostril the upper dose can be increased to 400 µg. The doses used in this study are 50, 100, 200 ad 400µg. Fentanyl may be administered for up to 6 pain episodes/ 24 hours. For each pain episode, a dose of NF is self-administrated in one nostril. If pain relief is not achieved, another dose of NF could be administered in the opposite nostril after 15 minutes.
The active substance is released gradually during its transit through the gastrointestinal tract. Slow release (SR) morphine is available in 5, 10, 30, 60, 100 and 200 mg. SR morphine is administered twice a day, usually every twelfth hour.