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Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer (NFCP1-2010)

Primary Purpose

Chronic Pain, Cancer

Status

Completed

Phase

Phase 1

Locations

Norway

Study Type

Interventional

Intervention

fentanyl

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring pain, adverse effects, safety, feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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
Pathological conditions of the nasal cavity as contraindication to nasal fentanyl
Sleep apnoea syndrome
Pregnant or breastfeeding women
Psychiatric disease

Sites / Locations

St.Olavs University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

fentanyl

Arm Description

cancer patients with pain

Outcomes

Primary Outcome Measures

sedation/drowsiness

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

nausea and vomiting

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

Secondary Outcome Measures

pain intensity

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

Full Information

NCT ID

NCT01248611

First Posted

November 18, 2010

Last Updated

May 9, 2014

Sponsor

St. Olavs Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01248611

Brief Title

Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer

Acronym

NFCP1-2010

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Olavs Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Cancer

Keywords

pain, adverse effects, safety, feasibility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

fentanyl

Arm Type

Experimental

Arm Description

cancer patients with pain

Intervention Type

Drug

Intervention Name(s)

fentanyl

Other Intervention Name(s)

Instanyl (nNcomed Pharma)

Intervention Description

nasally, dose titrated to effect

Primary Outcome Measure Information:

Title

sedation/drowsiness

Description

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

Time Frame

10 days

Title

nausea and vomiting

Description

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

Time Frame

10 days

Secondary Outcome Measure Information:

Title

pain intensity

Description

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

Time Frame

10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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 Pathological conditions of the nasal cavity as contraindication to nasal fentanyl Sleep apnoea syndrome Pregnant or breastfeeding women Psychiatric disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stein Kaasa, MD. PhD

Organizational Affiliation

St.Olav's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

St.Olavs University Hospital

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

24604566

Citation

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.

Results Reference

result

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Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer

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