Nasal Fentanyl for Chronic Cancer Pain

Pain Clinical Trial

— NFCP-2  

Official title:

An Open Label, Cross-over, Randomized Controlled Multicenter Phase III Study Comparing Standard Oral SR-morphine by the Clock Medications With Self-controlled Nasal Fentanyl for Chronic Cancer Pain Requiring Opioids

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01906073
• Other study ID #: NFCP-2
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: December 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Cancer disease

2. Adult (older than 18 years)

3. Cancer-related pain > 4 on an 11 point Numerical Rating Scale (NRS)

4. In the need of opioids (step II or III)

5. Able to use nasal drugs.

6. Life expectancy of > 6 months

7. Karnofsky status > = 60

8. Women of child bearing potential must use adequate contraception

9. Informed consent given according to applicable requirements before any trial-related activities.

Exclusion Criteria:

1. Use of opioids for moderate and severe pain

2. History of substance abuse.*

3. Pathological conditions of the nasal cavity as contraindication to nasal fentanyl

4. Renal- or liver- failure, defined as creatinin > 150 and alanine-amino transferase (ALAT) > x 1.5 reference value

5. Sleep apnoea syndrome, severe chronic obstructive lung disease or illnesses leading to severe respiratory depression.

6. Psychiatric disease

7. Neurological disease giving dizziness or sedation

8. Cognitive impairment which makes the patient unable to complete questionnaires or not able to comply with the study procedures.

9. Previous or ongoing facial radiotherapy

10. Recurrent nose bleeding

11. Known hypersensitivity to the active substances or excipients of the study drugs

12. Pregnant or breastfeeding women

13. Treated with monoamine oxidase (MAO) inhibitor within the last 14 days

Related Conditions & MeSH terms

• Cancer
• Cancer Pain
• Pain

Intervention

Drug:
• intranasal fentanyl spray

• slow release morphine

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the difference in patient reported satisfaction between the two treatment sessions	measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)	13 days
Secondary	Patient preference (overall; including pain relief, tolerance to adverse effects and convenience) of treatments after finishing the second part of the clinical study	5 point Likert scale	26 days
Secondary	Overall rating of average pain control in the two treatment phases	measured by an 11- point numeric rating scale	26 days
Secondary	Overall rating of average side effects in the two treatment phase	measured by an 11-point numeric rate scales	26 days