Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pain, Cancer

Intervention / Treatment
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* Drug: fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fentanyl<br>cancer patients with pain | Drug: fentanyl<br>* nasally, dose titrated to effect<br>* Other names: Instanyl (nNcomed Pharma);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity | scores on a 0-10 numerical rating scale; 0=none / 10=intolerable | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, adverse effects, safety, feasibility