Clinical trial

KETACANCER: Prospective Multicentre Study of the Use of Ketamine in the Treatment of Refractory Chronic Pain in the French CLCC

Name

ET20-130 - KETACANCER

Description

The primary objective of this study is to describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of indication (neuropathic sequelae pains, morphine additional effect or morphine withdrawal, intensity, localisation...) and administration protocol (route, posology, duration, administration sequence, premedication). The secondary objectives are to evaluate in the context of cancer, the analgesic efficacy, the tolerance profile (biological and clinical toxicities) and the quality of life, including anxiety and depression. In addition, the described parameters will be evaluated as safety and efficacy predictive factors of the Ketamine in oncology.

Trial arms

Trial start

2021-02-02

Estimated PCD

2023-02-06

Trial end

2023-03-09

Status

Completed

Treatment

Ketamine use in CLCC sites (indication and administration protocol)

Collection of information concerning Ketamine use by French CLCCs pain teams (first prescription): 1. Indications : analgesic treatment of cancer chronic pain, analgesic treatment for a post-cancer treatment chronic pain, help for withdrawal from opioid treatment prescribed for a chronic cancer pain 2. Administration protocol: route, posology, duration, administration sequence, premedication 3. Antalgic efficacy 4. Tolerance profile 5. Quality of life, anxiety and depression evaluations

Size

Primary endpoint

Describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of indication

Up to 3 months after inclusion

Describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of administration protocol

Up to 3 months after inclusion

Eligibility criteria

Inclusion Criteria: * Patient at least 18 years old at the day of consenting to the study * Patient followed for a solid tumour or a hematological malignancy (treated or under treatment) * Patient presenting cancer chronic pain or post cancer treatment pain * Patient followed by a CLCC's intractable chronic pain consultation or centre * Patient with an indication of 1st Ketamine course: * Analgesic treatment of cancer chronic pain * Analgesic treatment for a post-cancer treatment chronic pain * Help for withdrawal from opioid treatment prescribed for a chronic cancer pain * Patient not previously treated by Ketamine * Patient covered by a medical insurance * Patient and/or family did not decline data collection after complete information (information sheet) Exclusion Criteria: * Patient presenting chronic pains not related to cancer or its treatments * Patient with a proven psychotic history * Patient who is not fluent enough in French

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 81, 'type': 'ACTUAL'}}

Updated at

2023-09-11

1 organization

1 product

4 indications

Organization

Product

Indication

Indication

Indication

Indication