CancerSOOTHENCT04315831
Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain
An observational study of Cancer, run by Taiwan Mundipharma Pharmaceuticals Ltd. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Transdermal Buprenorphine
- How many people
- 83 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Jan 2018to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Caner patients with moderate to severe cancer pain
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Transdermal Buprenorphine
- Keywords
- Transdermal Buprenorphine, Cancer pain, QOL, NRS, Narcotics
- Medical subject headings
- Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal BuprenorphineDrug
Also called no other intervention
Intervention will be applied for patients with moderate to severe cancer pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse drug reaction
Number and percentage of patients with adverse drug reactions and serious adverse drug reactions
Measured: Week 3 to Week 4 or early termination
Secondary outcomes (6)
Pain intensity and interference
Pain intensity and interference measured by the Brief Pain Inventory (BPI)
Measured: 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
Measured: 1 month
Quality of life of the patients
Quality of life measured by the EORTC QLQ-C30
Measured: 1 month
Quality of sleep of the patients
Quality of sleep measured by a NRS
Measured: 1 month
Number of breakthrough pain
Number of breakthrough pain during the observational period
Measured: 1 month
Treatment discontinuation and associated reasons
reason for stop treatments
Measured: during study period-1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start31 Jan 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Mundipharma Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chang Gung Memorial Hospital, Changhua Christian Hospital, Taipei Medical University Shuang Ho Hospital
- Responsible party
- Sponsor
- Investigators
- Jen-Shi Chen, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315831
- Sponsor's protocol ID
- BUP17-TW-401
- Acronym
- SOOTHE
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share the individual participant data to other researchers unless formal request been reviewed and pproval
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. 2023 Apr;19(2):e45-e53. doi: 10.1111/ajco.13772. Epub 2022 May 22.
PubMed 35604203Shen 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.
PubMed 35362192
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain: an Observational Study (SOOTHE)
- ClinicalTrials.gov ID
- NCT04315831
- Acronym / sponsor ID
- SOOTHE / BUP17-TW-401
- Conditions
- Cancer
- Keywords
- Transdermal Buprenorphine, Cancer pain, QOL, NRS, Narcotics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Taiwan Mundipharma Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chang Gung Memorial Hospital, Changhua Christian Hospital, Taipei Medical University Shuang Ho Hospital
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Caner patients with moderate to severe cancer pain
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal BuprenorphineAlso: no other interventionIntervention will be applied for patients with moderate to severe cancer pain | Drug | – |
Primary outcome
Adverse drug reaction
Time frame: Week 3 to Week 4 or early termination
Number and percentage of patients with adverse drug reactions and serious adverse drug reactions
6 secondary outcomes
Pain intensity and interference
Time frame: whole study-1 month
Daily pain intensity measured by a numerical rating scale (NRS) by patients
Time frame: 1 month
Quality of life of the patients
Time frame: 1 month
Quality of sleep of the patients
Time frame: 1 month
Number of breakthrough pain
Time frame: 1 month
Treatment discontinuation and associated reasons
Time frame: during study period-1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Derived from this study: PubMed 35604203Huang 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.
- Derived from this study: PubMed 35362192Shen 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.
- Individual participant dataSharing planned: No. No plan to share the individual participant data to other researchers unless formal request been reviewed and pproval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jen-Shi Chen, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Taiwan Mundipharma Pharmaceuticals Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse drug reaction (time frame: Week 3 to Week 4 or early termination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04315831, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.