Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain (SOOTHE)

Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain: an Observational Study (SOOTHE)

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: Transdermal Buprenorphine

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.

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Chang Gung Memorial Hospital- Linko Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Caner patients with moderate to severe cancer pain

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECG changes	The change from baseline in ECG measurement at each visit	1 month of study period

Collaborators and Investigators

• Sponsor: Taiwan Mundipharma Pharmaceuticals Ltd.
• Collaborators: Chang Gung Memorial Hospital; Taipei Medical University Shuang Ho Hospital; Changhua Christian Hospital

Publications and helpful links

General Publications

• 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. 2022 May 22. doi: 10.1111/ajco.13772. Online ahead of print.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2018
• Primary Completion (ACTUAL): March 31, 2019
• Study Completion (ACTUAL): March 31, 2019

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (ACTUAL): March 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Transdermal Buprenorphine, Cancer pain, QOL, NRS, Narcotics
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: BUP17-TW-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share the individual participant data to other researchers unless formal request been reviewed and pproval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No