Nasal Fentanyl for Chronic Cancer Pain

Summary

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.

Conditions

• Cancer
• Pain

Interventions

DRUG

intranasal fentanyl spray

DRUG

slow release morphine

Sponsors & Collaborators

• St. Olavs Hospital

  collaborator OTHER

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  collaborator OTHER

• L'Hospitalet de Llobregat

  collaborator OTHER

• University Hospital, Bonn

  collaborator OTHER

• Cantonal Hospital of St. Gallen

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Flinders University

  collaborator OTHER

• Norwegian University of Science and Technology

  lead OTHER

Principal Investigators

• Stein Kaasa, MD prof · Norwegian University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2020-12-31

Completion

2020-12-31