Clinical trial NCT04315831: Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain
Official title: Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain: an Observational Study (SOOTHE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Transdermal Buprenorphine, Cancer pain, QOL, NRS, Narcotics
Lead sponsor: Taiwan Mundipharma Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chang Gung Memorial Hospital
name: Changhua Christian Hospital
name: Taipei Medical University Shuang Ho Hospital
First posted: 2020-03-20
Enrollment: 83
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caner patients with moderate to severe cancer pain

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Cancer patients aged 20 years old and over
2. ECOG \<3
3. Moderate or severe pain intensity with stable titration from previous opioid analgesics, 7 days at least prior to enrolment and with the dose equivalent to oral morphine ranging from 60 to 120 mg/day in previous treatment
4. Cancer-related pain that requires treatment with continuous around-the-clock strong opioid analgesic
5. Patients who are going to start Transtec treatment per clinical judgment, according to the locally approved labeling, are eligible.
6. Patients who are able to communicate and fill out the questionnaire forms
7. Patient provided signed informed consent

Exclusion Criteria:

1. Patients diagnosed with non-cancer pain or unexplained pain
2. Patients who have constipation (CTCAE grade 3 and above)
3. Patients with uncontrolled or unstable cardiac disease
4. Abnormal lab results, with obvious clinical significance, such as ALT or AST\>= 3 fold of upper limit of normal value or liver function of Child C grade prior to study
5. ALT or AST \>= 5 fold of upper limit of normal value for patients with liver metastasis or primary liver cancer
6. Pregnant or nursing (lactating) women
7. Patients who are drug or alcohol abuse
8. Patients who have hypersensitivity to buprenorphine
9. Patients who are clinically unstable or have a life expectancy of less than 8 weeks making completion of the trial unlikely
10. With any contraindications or using prohibited medication per locally approved

Primary outcomes:
measure: Adverse drug reaction
timeFrame: Week 3 to Week 4 or early termination
Secondary outcomes:
measure: Pain intensity and interference
timeFrame: whole study-1 month
measure: Daily pain intensity measured by a numerical rating scale (NRS) by patients
timeFrame: 1 month
measure: Quality of life of the patients
timeFrame: 1 month
measure: Quality of sleep of the patients
timeFrame: 1 month
measure: Number of breakthrough pain
timeFrame: 1 month
measure: Treatment discontinuation and associated reasons
timeFrame: during study period-1 month
Other outcomes:
measure: ECG changes
timeFrame: 1 month of study period
Locations:
city: New Taipei City
country: Taiwan
facility: Chang Gung Memorial Hospital- Linko Branch
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Jen-Shi Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.