Today, patients with cancer pain in need of opioids for moderate to severe pain get
long-acting morphine twice a day and morphine tablets taken on demand in addition. This
procedure might be based on the assumption that cancer pain is persistent, although the
evidence to support whether this assumption applies to all cancer patients is lacking. Some
cancer patients might not need a fixed dose of long-acting morphine.
Because of rapid pain relief, the new fentanyl drugs open for the possibility to take an
opioid on demand when pain occurs.
A pilot study where 10 patients with cancer pain were treated with a rapid-acting fentanyl
nasal spray taken on demand, showed that this treatment was apparently feasible and safe for
these patients.
This approach is studied further in NFCP-II. The participants will be treated with
rapid-acting fentanyl nasal spray and long-acting morphine in a crossover study. The primary
outcome will be patient satisfaction.
The study will consist of a test dose of nasal fentanyl, a dose-finding phase and a treatment
phase with either nasal fentanyl taken on demand or slow-released morphine taken twice a day.
After 10 days of treatment there is a crossover and the opposite drug is used for the same
participant. Morphine tablets can be taken on demand in all phases of the study.
The participants will meet the investigator at inclusion, at the crossover and at the end of
treatment. During the study, a diary is filled in by the participants every morning.
Questions about pain and side effects are answered. Satisfaction is measured at the crossover
and at end of treatment while preference is measured at the end of treatment.
Phase:
Phase 3
Details
Lead Sponsor:
Norwegian University of Science and Technology
Collaborators:
Cantonal Hospital of St. Gallen Flinders University Fondazione IRCCS Istituto Nazionale dei Tumori, Milano L'Hospitalet de Llobregat Maastricht University Medical Center St. Olavs Hospital University Hospital, Bonn