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| Name | Class |
|---|---|
| Chang Gung Memorial Hospital | OTHER |
| Changhua Christian Hospital | OTHER |
| Taipei Medical University Shuang Ho Hospital | OTHER |
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Buprenorphine transdermal patch is newly available in Taiwan in June 2017, the trade name is Transtec, and the available dosages are 35 μg/h and 52.5 μg/h. Taiwan is the first Asia country which launched Transtec for cancer pain treatment. Although the efficacy of transdermal buprenorphine has been demonstrated in some randomized, placebo-controlled studies and also conducted a large scale post-marketing surveillance study in Germany, therefore the local scientific data is required for Asia experience. Due to above rationale, this observational study will be initiated in Taiwan, to build up the first real-world scientific data in Asia.
The objective of this study is to collect the safety and effectiveness of transdermal buprenorphine in routine clinical practice, in particular, to collect data in population with controlled cancer pain and stable titration from previous opioid analgesics in Taiwan.
The objective of this observational study is to collect effectiveness and safety data on the labelled use of buprenorphine transdermal patches (Transtec 35 μg/h and 52.5 μg/h) under regular and routine clinical conditions in Taiwan for cancer patients with moderate to severe cancer pain (NRS Score>=4) and strong opioids are needed for their pain treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal Buprenorphine | Drug | Intervention will be applied for patients with moderate to severe cancer pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse drug reaction | Number and percentage of patients with adverse drug reactions and serious adverse drug reactions | Week 3 to Week 4 or early termination |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity and interference | Pain intensity and interference measured by the Brief Pain Inventory (BPI) | whole study-1 month |
| Daily pain intensity measured by a numerical rating scale (NRS) by patients |
| Measure | Description | Time Frame |
|---|---|---|
| ECG changes | The change from baseline in ECG measurement at each visit | 1 month of study period |
Inclusion Criteria:
Exclusion Criteria:
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Caner patients with moderate to severe cancer pain
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| Name | Affiliation | Role |
|---|---|---|
| Jen-Shi Chen, MD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital- Linko Branch | New Taipei City | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35604203 | Derived | Huang TL, Huang YM, Hou MM, Lu CH, Chao TY, Chiu TJ, Chang YS, Lin SH, Lin CH, Chen YH, Wang CH, Chen JS, Shen WC. Safety and effectiveness of transdermal buprenorphine in cancer pain: An observational study in Taiwan (SOOTHE). Asia Pac J Clin Oncol. 2023 Apr;19(2):e45-e53. doi: 10.1111/ajco.13772. Epub 2022 May 22. | |
| 35362192 | Derived |
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No plan to share the individual participant data to other researchers unless formal request been reviewed and pproval
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Daily pain intensity measured by a numerical rating scale (NRS) designed in a patient diary card
| 1 month |
| Quality of life of the patients | Quality of life measured by the EORTC QLQ-C30 | 1 month |
| Quality of sleep of the patients | Quality of sleep measured by a NRS | 1 month |
| Number of breakthrough pain | Number of breakthrough pain during the observational period | 1 month |
| Treatment discontinuation and associated reasons | reason for stop treatments | during study period-1 month |
| Shen WC, Hou MM, Huang TL, Wang CH, Huang YM, Chen JS, Chen ML. Transdermal buprenorphine improves overall quality of life and symptom severity in cancer patients with pain. J Clin Nurs. 2023 Feb;32(3-4):539-547. doi: 10.1111/jocn.16303. Epub 2022 Mar 31. |