Clinical trial NCT05265442: Real-life Observational Study of Cancer Pain Management With Methadone
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Pain
Lead sponsor: RECORDATI GROUP
Sponsor class: INDUSTRY
First posted: 2022-03-03
Enrollment: 136
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of patients suffering from either one or the other following complications from D1 to DOD
timeFrame: around one week
Secondary outcomes:
Other outcomes:
Locations:
city: Puteaux
country: France
facility: LBR
Study officials:
affiliation: CLCC Leon Berard- Lyon - France
name: Gisele Chvetzoff, Pr
role: PRINCIPAL_INVESTIGATOR
References: