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

NCT04459234 | Completed

• 1 other identifier: ET20-130 - KETACANCER
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Cancer; Chronic Pain; Neuropathic Pain; Opioid Use

Keywords

Cancer; Palliative care; Ketamine; Chronic pain

Outcome Measures

Primary Outcomes (2)

• 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

  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

  route, posology, duration, administration sequence, premedication

  Up to 3 months after inclusion

Secondary Outcomes (6)

• Evaluate in the context of cancer the antalgic efficacy

  Up to 3 months after inclusion

• Evaluate in the context of cancer the antalgic efficacy

  Up to 3 months after inclusion

• Evaluate in the context of cancer the antalgic efficacy

  Up to 3 months after inclusion

• Evaluate in the context of cancer the tolerance profile

  Up to 3 months after inclusion

• Evaluate in the context of cancer the quality of life including anxiety and depression

  Up to 3 months after inclusion

Interventions

Ketamine use in CLCC sites (indication and administration protocol) DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective, multicentre study, considered as " non-RIPH (Recherche n'Impliquant pas la Personne Humaine ". Indeed, the patient's participation in the study and the completion of the various questionnaires has no impact on patient's safety and is not likely to change his/her management. The treatment will be conducted according to the standard practices of each participating site (continuous or discontinuous protocol, dosage, rhythm of administration, monitoring, etc.). The questionnaires and scales used in this study are part of the recommended tools for monitoring this population.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (12)

Institut Bergonié

Bordeaux, 33076, France

Location

Centre François Baclesse

Caen, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Institut de Cancérologie de Montpellier

Montpellier, 34298, France

Location

Institut Curie

Paris, 75005, France

Location

Institut Godinot

Reims, 51056, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Institut Universitaire du Cancer (IUCT)

Toulouse, 31059, France

Location

Institut de Cancérologie de Lorraine Alexis Vautrin

Vandœuvre-lès-Nancy, 54519, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Neoplasms; Chronic Pain; Neuralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Gisèle CHVETZOFF, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: February 2, 2021
• Primary Completion: February 6, 2023
• Study Completion: March 9, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

FR (12)