Real-life Observational Study of Cancer Pain Management With Methadone

NCT05265442 | Completed

• 1 other identifier: METHADONE-LBR-NI-0571
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer Pain

Outcome Measures

Primary Outcomes (1)

• 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)

  around one week

Interventions

Methadone DRUG

titration of Zoryon (methadone): increase of posology untill pain relieved is reached

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RECORDATI GROUP: lead

Study Sites (1)

LBR

Puteaux, France

Location

MeSH Terms

Conditions

Cancer Pain

Interventions

Methadone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Gisele Chvetzoff, Pr

  CLCC Leon Berard- Lyon - France

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: February 21, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 31, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)