Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer

NCT ID: NCT01248611

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-09-30

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.

Conditions

Chronic Pain; Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fentanyl

cancer patients with pain

Group Type: EXPERIMENTAL

fentanyl

Intervention Type: DRUG

nasally, dose titrated to effect

Interventions

fentanyl

nasally, dose titrated to effect

Intervention Type: DRUG

Other Intervention Names

Instanyl (nNcomed Pharma)

Eligibility Criteria

Inclusion Criteria

1. Cancer patients with metastatic disease

2. Adult (older than 18 years)

3. Life expectancy of > 3 months

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

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

6. Able to use nasal drugs.

7. Women of child bearing potential using adequate contraception

8. 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

Exclusion Criteria

1. History of substance abuse

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

3. Treated with MAO inhibitor within the last 14 days

4. Known hypersensitivity to study drug or specific contraindications to the study drug

5. Nasopharyngeal device such as gastric tube

6. Concomitant participation in any other trials dealing with pain with an investigational drug or device apart from cancer treatment within 14 days prior to inclusion in this trial

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

8. Sleep apnoea syndrome

9. Pregnant or breastfeeding women

10. Psychiatric disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stein Kaasa, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

St.Olav's Hospital

Locations

St.Olavs University Hospital

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 24604566 (View on PubMed)

Other Identifiers

NFCP1-2010

Identifier Type: -

Identifier Source: org_study_id