Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer

Cancer Clinical Trial

— NFCP1-2010  

Official title:

Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer An Open Label Prospective Phase I b Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248611
• Other study ID #: NFCP1-2010
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 18, 2010
• Last updated: May 9, 2014
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: May 2014
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Chronic Pain

Intervention

Drug:
• fentanyl
nasally, dose titrated to effect

Locations

Country	Name	City	State
Norway	St.Olavs University Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Thronæs 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sedation/drowsiness	scores on a 0-10 numerical rating scale; 0=none / 10=intolerable	10 days	Yes
Primary	nausea and vomiting	nausea scores on a 0-10 numerical rating scale; 0=none / 10=intolerable vomiting yes/no	10 days	Yes
Secondary	pain intensity	scores on a 0-10 numerical rating scale; 0=none / 10=intolerable	10 days	No