Cancer PainDUNENCT05265442
Real-life Observational Study of Cancer Pain Management With Methadone
An observational study of Cancer Pain, run by RECORDATI GROUP at 1 site in France.
Trial summary
Study rational. Methadone is a distinctive opioid because of its pharmacological characteristics and its multiple modes of action, reinforcing its therapeutic value in managing advanced cancer pain, particularly in cases with a neuropathic component. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Methadone
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2022to 31 Dec 2023
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with intractable cancer pain inadequately relieved by other opioids (ineffective and/or excessive adverse events) AND for whom switching from opioid to Zoryon® has been prescribed.
Who may be able to join
- Patients with intractable cancer pain inadequately relieved by other opioids (ineffective and/or excessive adverse events) AND for whom switching from opioid to Zoryon® has been prescribed.
- be aged 15 years or older;
- suffer from cancer pain;
- be treated with a level 3 opioid with inadequate pain relief, i.e., ineffective, excessive adverse effects, or both;
- have a prescription to initiate Zoryon® treatment.
Who cannot join
- patients participating, or having participated within the previous month, in a clinical trial evaluating a new pain management treatment will be excluded, except for patients participating in the French experimentation of the use of therapeutical cannabis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DUNE - A Real-life Observational Study of Cancer Pain Management With Methadone (Zoryon®) in Patients Inadequately Relieved by Other Level 3 Opioids.
Study rational. Methadone is a distinctive opioid because of its pharmacological characteristics and its multiple modes of action, reinforcing its therapeutic value in managing advanced cancer pain, particularly in cases with a neuropathic component. However, the complex pharmacodynamics of methadone makes its prescription sometimes challenging. There is a wide inter-individual variability of its half-life. This long half-life is a valued characteristic for the management of patients treated for an addictive disorder. However, in the context of pain management, it greatly complicates the switch from and to another opioid, accentuating the risk of overdose. This is the reason why LBR, willing to improve his knowledge about Methadone in real life clinical practice wants to performe this study.
We anticipate that most patients will receive one of the above-described protocols, but we must anticipate that other protocols may be used in clinical practice in the absence of specific recommendations. Therefore it is of utmost relevance to describe the safety when initiating treatment with Zoryon® during the crucial period from D1 until the day of optimal dosage is determined (DOD) as the clinical practice may vary from a practician to another, and then until the routine follow-up visit one month after initiation of the treatment (D28).
Read the detailed description
To describe the occurrence of overdose and QTc prolongation in patients initiating a treatment with Zoryon® for intractable cancer pain not adequately relieved from other level 3 opioids, from the day of instauration (D1) to the day of determination of the optimal dose for the patient (DOD: Day of Optimal Dosage (DOD): the dosage of Zoryon® will be considered optimal after two consecutive days without modification to the posology (usually within the first week) AND pain relief for the patient.
- Conditions
- Cancer Pain
- Being tested
- Methadone
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
titration of Zoryon (methadone): increase of posology untill pain relieved is reached
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients suffering from either one or the other following complications from D1 to DOD
- Overdose episode, defined by a Richmond score ≤ -4 and a respiratory rate < 8 / min
- QTc prolongation episode, defined by an episode > 500 ms (grade 3 according to CTCAE)
Measured: around one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start21 Feb 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- RECORDATI GROUP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gisele Chvetzoff, Pr, Principal investigator, CLCC Leon Berard- Lyon - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265442
- Sponsor's protocol ID
- METHADONE-LBR-NI-0571
- Acronym
- DUNE
- Status last verified
- Aug 2024
- First submitted
- 22 Feb 2022
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DUNE - A Real-life Observational Study of Cancer Pain Management With Methadone (Zoryon®) in Patients Inadequately Relieved by Other Level 3 Opioids.
- ClinicalTrials.gov ID
- NCT05265442
- Acronym / sponsor ID
- DUNE / METHADONE-LBR-NI-0571
- Conditions
- Cancer Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- RECORDATI GROUPIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 Mar 2022 (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.
Study rational. Methadone is a distinctive opioid because of its pharmacological characteristics and its multiple modes of action, reinforcing its therapeutic value in managing advanced cancer pain, particularly in cases with a neuropathic component. However, the complex pharmacodynamics of methadone makes its prescription sometimes challenging. There is a wide inter-individual variability of its half-life. This long half-life is a valued characteristic for the management of patients treated for an addictive disorder. However, in the context of pain management, it greatly complicates the switch from and to another opioid, accentuating the risk of overdose. This is the reason why LBR, willing to improve his knowledge about Methadone in real life clinical practice wants to performe this study.
We anticipate that most patients will receive one of the above-described protocols, but we must anticipate that other protocols may be used in clinical practice in the absence of specific recommendations. Therefore it is of utmost relevance to describe the safety when initiating treatment with Zoryon® during the crucial period from D1 until the day of optimal dosage is determined (DOD) as the clinical practice may vary from a practician to another, and then until the routine follow-up visit one month after initiation of the treatment (D28).
Detailed description
To describe the occurrence of overdose and QTc prolongation in patients initiating a treatment with Zoryon® for intractable cancer pain not adequately relieved from other level 3 opioids, from the day of instauration (D1) to the day of determination of the optimal dose for the patient (DOD: Day of Optimal Dosage (DOD): the dosage of Zoryon® will be considered optimal after two consecutive days without modification to the posology (usually within the first week) AND pain relief for the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with intractable cancer pain inadequately relieved by other opioids (ineffective and/or excessive adverse events) AND for whom switching from opioid to Zoryon® has been prescribed.
Key inclusion criteria (5 listed)
- Patients with intractable cancer pain inadequately relieved by other opioids (ineffective and/or excessive adverse events) AND for whom switching from opioid to Zoryon® has been prescribed.
- be aged 15 years or older;
- suffer from cancer pain;
- be treated with a level 3 opioid with inadequate pain relief, i.e., ineffective, excessive adverse effects, or both;
- have a prescription to initiate Zoryon® treatment.
Key exclusion criteria (1 listed)
- patients participating, or having participated within the previous month, in a clinical trial evaluating a new pain management treatment will be excluded, except for patients participating in the French experimentation of the use of therapeutical cannabis
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 |
|---|---|---|
| Methadonetitration of Zoryon (methadone): increase of posology untill pain relieved is reached | Drug | – |
Primary outcome
Rate of patients suffering from either one or the other following complications from D1 to DOD
Time frame: around one week
* Overdose episode, defined by a Richmond score ≤ -4 and a respiratory rate < 8 / min * QTc prolongation episode, defined by an episode > 500 ms (grade 3 according to CTCAE)
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 31 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Gisele Chvetzoff, Pr principal investigator
CLCC Leon Berard- Lyon - France
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 Pain, run by RECORDATI GROUP at 1 site in France.
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 5 inclusion and 1 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 31 Oct 2024. 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 France. 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?
Rate of patients suffering from either one or the other following complications from D1 to DOD (time frame: around one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2024.