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

Sponsor

Centre Leon Berard (Other)

Overall Status

Recruiting

CT.gov ID

NCT04459234

Collaborator

(none)

150

Enrollment

Locations

25.9

Anticipated Duration (Months)

12.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Chronic Pain Neuropathic Pain Opioid Use	Drug: Ketamine use in CLCC sites (indication and administration protocol)

Detailed Description

Almost 382,000 new cancers have been diagnosed in France in 2018. Regular progresses in their management have improved the overall survival of patients, sometimes with sequelae that may be particularly painful. Thus for 20 to 45% of patients treated for breast cancer, pain persists 5 years later.

If remission is a regularly reached target, cancer was also the cause of 157,000 deaths in 2018 in France, preceded by months or years of progression of a chronic disease that regularly causes pain. Pain during cancer (chronic cancer pain for CIM-11) remains a frequent symptom, and its prevalence has slightly changed during the last 20 years.

In the European EPIC study, carried out in 2006, 76% of the cancer patients (and 62% of French patients) presented moderate to severe pains linked to cancer, daily for more than half of them.

Even when identified, chronic cancer pain is still under-treated in 25 to 60% of cases worldwide, including in the most developed countries.

When well-managed, pain's management now allows the relief of almost 80% of patients. Pain's management is based in particular on a precise and adapted use of the different opioids through different routes of administration (oral, transdermal, trans-mucosal, parenteral, etc.).

A neuropathic component of pain exists in almost a third of cases and may require specific treatments when opioids are insufficient. In all cases, the treatment is integrated into a multidisciplinary management, in connection with the ongoing oncological treatments, the loco-regional treatments available (radiotherapy, interventional radiology, etc.) and with an adapted psychosocial management.

Ketamine is an NMDA receptor antagonist (N-Methyl-D-Aspartate) indicated as a high dose anesthetic. It is used in the context of peri-operative pain for its anti-hyperalgesic properties. These properties have led to its use also in palliative care (outside the marketing authorization [AMM]) to treat hyperalgesia linked to the use of high-doses of opioids, as well as depression. For non-cancer pains, ketamine is widely used by centres and consultations specialized in refractory chronic pain management in different pains not relieved by standard treatments: neuropathic pain, fibromyalgia, etc., or even in opioids weaning aid.

The bibliographic data are not homogeneous and of low quality. Despite the weakness of the available data, ketamine is widely used in France in chronic pain in situation of therapeutic impasse. The protocols used vary according to the prescribers and services practices: venous route in general, sometimes subcutaneous or even oral; doses varying from 30 to 200 mg / day, infusion duration varying from a few hours to several days, discontinuous administration by cycle or continuous administration, etc.

Current knowledge is too limited in oncology to have a consensus on the use of ketamine :

Often retrospective studies with heterogeneous treatment protocols;
Studied populations also heterogeneous, with insufficiently documented indications;
Staff not able to answer adequately the questions raised. This situation largely explains the heterogeneity of the Ketamine practices of use in oncology

It is essential to draw up an inventory of the ketamine use by the French CLCCs pain teams and to identify the profile of patients in whom i) the treatment is ineffective and must be avoided regarding toxicities ii) the potential efficacy required further investigations. Built on a methodology close to the OKAPI study, the KETACANCER study will enable to compare indirectly the results of the two studies.

To do this, it is proposed to conduct the KETACANCER prospective study in a precise population defined a priori, and corresponding to the following indications:

Neuropathic sequelae pain
Additional effect of morphine
Morphine weaning.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 2, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Outcome Measures

Primary Outcome Measures

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]
neuropathic sequelae pains, morphine additional effect or morphine withdrawal, intensity, localisation
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]
route, posology, duration, administration sequence, premedication

Secondary Outcome Measures

Evaluate in the context of cancer the antalgic efficacy [Up to 3 months after inclusion]
Questionnaire: NPSI
Evaluate in the context of cancer the antalgic efficacy [Up to 3 months after inclusion]
Questionnaire: DN4
Evaluate in the context of cancer the antalgic efficacy [Up to 3 months after inclusion]
Questionnaire: PGIC
Evaluate in the context of cancer the tolerance profile [Up to 3 months after inclusion]
The safety will be described mainly on the frequency of adverse events coded using the common toxicity criteria (NCI-CTCAE v5.0) grade. Descriptive statistics will be provided for characterizing and assessing patient's tolerance to treatment. Adverse events will be coded according to the MedDRA®.
Evaluate in the context of cancer the quality of life including anxiety and depression [Up to 3 months after inclusion]
Numeric scale (from 0 : no pain to 10: maximum pain)
Evaluate in the context of cancer the quality of life including anxiety and depression [Up to 3 months after inclusion]
Questionnaire: HADS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institut Bergonié	Bordeaux	France	33076
2	Centre François Baclesse	Caen	France
3	Centre Jean Perrin	Clermont-Ferrand	France	63011
4	Centre Leon Berard	Lyon	France	69008
5	Institut Paoli Calmettes	Marseille	France	13273
6	Institut de Cancérologie de Montpellier	Montpellier	France	34298
7	Institut Curie	Paris	France	75005
8	Institut Godinot	Reims	France	51056
9	Centre Eugène Marquis	Rennes	France	35042
10	Institut Universitaire du Cancer (IUCT)	Toulouse	France	31059
11	Institut de Cancérologie de Lorraine Alexis Vautrin	Vandoeuvre les nancy	France	54519
12	Institut Gustave Roussy	Villejuif	France	94805