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.
Study Type
OBSERVATIONAL
Enrollment
83
Intervention will be applied for patients with moderate to severe cancer pain
Chang Gung Memorial Hospital- Linko Branch
New Taipei City, Taiwan
Adverse drug reaction
Number and percentage of patients with adverse drug reactions and serious adverse drug reactions
Time frame: Week 3 to Week 4 or early termination
Pain intensity and interference
Pain intensity and interference measured by the Brief Pain Inventory (BPI)
Time frame: whole study-1 month
Daily pain intensity measured by a numerical rating scale (NRS) by patients
Daily pain intensity measured by a numerical rating scale (NRS) designed in a patient diary card
Time frame: 1 month
Quality of life of the patients
Quality of life measured by the EORTC QLQ-C30
Time frame: 1 month
Quality of sleep of the patients
Quality of sleep measured by a NRS
Time frame: 1 month
Number of breakthrough pain
Number of breakthrough pain during the observational period
Time frame: 1 month
Treatment discontinuation and associated reasons
reason for stop treatments
Time frame: during study period-1 month
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