Fentanyl for Treatment Pain Caused by Radiotherapy

Study Overview
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Brief Summary
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The purpose of this study is to assess the clinical utility and safety of Fentanyl for pain treatment caused by radiotherapy. Fentanyl is a synthetic pure opioid agonist with a selective activity on µ receptors.

Detailed Description
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The study is a phase IV, open label, single arm study. The purpose of this study is to assess the clinical utility and safety of fentanyl transdermal therapeutic system (patch) for treatment of pain caused by radiotherapy. The patients increase or even decrease the amount of study medication in order to achieve pain relief, 48 to 72 hours or 3 days are required after the first patch application. The study medication will be used for 4 weeks. VAS (visual analog scale), BPI Q9 (quality of life) and global assessment have been used to assess the effectiveness. VAS will be assessed every week. BPI Q9 will be assessed at week 1 and week 4. Global assessment will be assessed at week 4. The safety of the study drug will be evaluated using adverse event (AE) report. The investigator will assess the pain intensity of patients and increase or even decrease Fentanyl dosage every week. Fentanyl will be started on 25 or 50 ug per hr depending on investigator's judgement. Fentanyl will be administered for 4 weeks.

Official Title
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Post-Marketing Surveillance of Durogesic for Treatment Pain Caused by Radiotherapy

Conditions
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Pain

Intervention / Treatment
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* Drug: Fentanyl transdermal therapeutic system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients have the history of head and neck tumor Patients who are proceeding radiotherapy Patients who are administered weak opioids and pain score (Visual analog scale) of 4 Exclusion Criteria: Patients who have been administered Fentanyl for pain treatment within 2 weeks before the study Patients who will have surgery within 1 month Known presence of distant metastasis

Ages Eligible for Study
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Minimum Age: 19 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fentanyl transdermal therapeutic system|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the clinical utility of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy. VAS (at week 1 4), BPI Q9 (week 1 and 4) and global assessment (week 4) have been used to assess the clinical utility. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy using AE (adverse event) report at every visit. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation pain, Duragesic, Fentanyl, Pain