NCT01248611

Brief Summary

Traditionally cancer pain is treated with long acting opioids such as morphine around the clock. However, there is no evidence that all patients have a stable pain requiring around the clock medication. So far opioids for self-administration with a rapid onset of action have not been available. Recently a nasal formulation of fentanyl (an opioid similar to morphine) was released in Europe for treatment of breakthrough pain, i.e. an unpredictable pain with short duration that breaks through the otherwise stable pain controlled with the around the clock medication. The basic idea is that this formulation may open for patient controlled analgesia of chronic cancer pain, due to the ultra rapid onset of action of nasally delivered fentanyl. This means that the patient only takes medication when in pain. This single center feasibility / safety study is the first part of a study to investigate this alternative cancer pain treatment approach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 chronic-pain

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_1 chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

November 18, 2010

Last Update Submit

May 9, 2014

Conditions

Chronic PainCancer

Keywords

painadverse effectssafetyfeasibility

Outcome Measures

Primary Outcomes (2)

  • sedation/drowsiness

    scores on a 0-10 numerical rating scale; 0=none / 10=intolerable

    10 days

  • nausea and vomiting

    nausea scores on a 0-10 numerical rating scale; 0=none / 10=intolerable vomiting yes/no

    10 days

Secondary Outcomes (1)

  • pain intensity

    10 days

Study Arms (1)

fentanyl

EXPERIMENTAL

cancer patients with pain

Drug: fentanyl

Interventions

fentanylDRUG

nasally, dose titrated to effect

Also known as: Instanyl (nNcomed Pharma)
fentanyl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer patients with metastatic disease
  • Adult (older than 18 years)
  • Life expectancy of \> 3 months
  • Cancer-related pain \> 3 on an 11 point Numerical Rating Scale (NRS)
  • In the need of opioids (step II or III)
  • Able to use nasal drugs.
  • Women of child bearing potential using adequate contraception
  • Informed consent given according to applicable requirements before any trial-related activities. Trial-related activities are any procedure that would not have been performed during the routine management of the patient

You may not qualify if:

  • History of substance abuse
  • Cognitive impairment which makes the patient unable to complete questionnaires or not able to comply with the study procedures
  • Treated with MAO inhibitor within the last 14 days
  • Known hypersensitivity to study drug or specific contraindications to the study drug
  • Nasopharyngeal device such as gastric tube
  • Pathological conditions of the nasal cavity as contraindication to nasal fentanyl
  • Sleep apnoea syndrome
  • Pregnant or breastfeeding women
  • Psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St.Olavs University Hospital

Trondheim, 7006, Norway

Location

Related Publications (1)

  • Thronaes M, Kaasa S, Dale O. A pilot study of nasal fentanyl for patient controlled treatment of cancer pain. J Opioid Manag. 2014 Jan-Feb;10(1):21-8. doi: 10.5055/jom.2014.0188.

    PMID: 24604566RESULT

MeSH Terms

Conditions

Chronic PainNeoplasmsPain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Stein Kaasa, MD. PhD

    St.Olav's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 25, 2010

Study Start

January 1, 2011

Primary Completion

May 1, 2011

Study Completion

September 1, 2011

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

NO(1)