The Pain Pen for Breakthrough Cancer Pain

Study Overview
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Brief Summary
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The purpose of this study is to see whether injection of hydromorphone through a subcutaneous injection device is more effective in treating breakthrough cancer pain than oral morphine.

Detailed Description
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Breakthrough pain is an exacerbation of severe pain that occurs on a background of otherwise controlled pain. Breakthrough pain is common in patients with advanced cancer. Current medications to treat breakthrough pain include oral immediate release opioid formulations and more recently oral transmucosal fentanyl citrate. The pain pen study is a randomized controlled double blind cross-over study comparing the efficacy of oral immediate release morphine with that of subcutaneous hydromorphone, injected through a so called pain pen, on breakthrough pain in cancer patients. Preliminary experience with the pain pen suggests that it has a more rapid time of onset of pain relief than oral formulations.

Official Title
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Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen

Conditions
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Neoplasms, Pain

Intervention / Treatment
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* Drug: Subcutaneous hydromorphone delivered by pain pen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable cancer pain requiring the equivalent of 60-1000 mg oral morphine/day 1-4 breakthrough pain episodes/day Patients must be able, in the opinion of the investigator, to fully comply with trial requirements Patients who have given written informed consent Exclusion Criteria: Uncontrolled pain Women who are pregnant, lactating or intend to become pregnant Cardiopulmonary disease that would increase the risk of opioids Neurologic or psychiatric disease that would compromise data collection Recently started chemotherapy or radiotherapy in as far as it would be effective in lowering breakthrough pain

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Subcutaneous hydromorphone delivered by pain pen|Subcutaneous hydromorphone delivered by pain pen during breakthrough pain episodes, at max 4 daily. Dose established by opioid conversion from baseline opioids.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity difference (PID) at t=15 minutes |  | t=15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PID 5' |  | 5 min | 
| PID 30' |  | 30 min | 
| PID 45' |  | 45 min | 
| PID 60' |  | 60 minutes | 
| time to onset of meaningful pain relief |  | time to onset | 
| global efficacy rating at 60' |  | 60 min |