Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain

NCT04315831 | Completed

• 1 other identifier: BUP17-TW-401
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Transdermal Buprenorphine, Cancer pain, QOL, NRS, Narcotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pain intensity and interference

  whole study-1 month

• Daily pain intensity measured by a numerical rating scale (NRS) by patients

  1 month

• Quality of life of the patients

  1 month

• Quality of sleep of the patients

  1 month

• Number of breakthrough pain

  1 month

Other Outcomes (1)

• ECG changes

  1 month of study period

Interventions

Transdermal Buprenorphine DRUG

Intervention will be applied for patients with moderate to severe cancer pain

Also known as: no other intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caner patients with moderate to severe cancer pain

You may qualify if:

• Cancer patients aged 20 years old and over
• ECOG \<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
• Cancer-related pain that requires treatment with continuous around-the-clock strong opioid analgesic
• Patients who are going to start Transtec treatment per clinical judgment, according to the locally approved labeling, are eligible.
• Patients who are able to communicate and fill out the questionnaire forms
• Patient provided signed informed consent

You may not qualify if:

• Patients diagnosed with non-cancer pain or unexplained pain
• Patients who have constipation (CTCAE grade 3 and above)
• Patients with uncontrolled or unstable cardiac disease
• 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
• ALT or AST \>= 5 fold of upper limit of normal value for patients with liver metastasis or primary liver cancer
• Pregnant or nursing (lactating) women
• Patients who are drug or alcohol abuse
• Patients who have hypersensitivity to buprenorphine
• Patients who are clinically unstable or have a life expectancy of less than 8 weeks making completion of the trial unlikely
• With any contraindications or using prohibited medication per locally approved

Sponsors & Collaborators

• Taiwan Mundipharma Pharmaceuticals Ltd.: lead
• Chang Gung Memorial Hospital: collaborator
• Changhua Christian Hospital: collaborator
• Taipei Medical University Shuang Ho Hospital: collaborator

Study Sites (1)

Chang Gung Memorial Hospital- Linko Branch

New Taipei City, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 35604203 DERIVED

• 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.

  PMID: 35362192 DERIVED

MeSH Terms

Conditions

Neoplasms; Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jen-Shi Chen, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 20, 2020
• Study Start: January 31, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)