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)
183
Enrollment
10
Locations
17.9
Anticipated Duration (Months)
18.3
Patients Per Site
1
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 DiseaseIntervention/TreatmentPhase
  • 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 :
183 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 :
Feb 2, 2022
Anticipated Study Completion Date :
Aug 2, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. Evaluate in the context of cancer the antalgic efficacy [Up to 3 months after inclusion]

    Questionnaire: NPSI

  2. Evaluate in the context of cancer the antalgic efficacy [Up to 3 months after inclusion]

    Questionnaire: DN4

  3. Evaluate in the context of cancer the antalgic efficacy [Up to 3 months after inclusion]

    Questionnaire: PGIC

  4. 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®.

  5. 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)

  6. 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:
No
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

SiteCityStateCountryPostal Code
1Institut BergoniéBordeauxFrance33076
2Centre Jean PerrinClermont-FerrandFrance63011
3Centre Leon BerardLyonFrance69008
4Institut Paoli CalmettesMarseilleFrance13273
5Institut de Cancérologie de MontpellierMontpellierFrance34298
6Institut CurieParisFrance75005
7Institut GodinotReimsFrance51056
8Centre Eugène MarquisRennesFrance35042
9Institut Universitaire du Cancer (IUCT)ToulouseFrance31059
10Institut de Cancérologie de Lorraine Alexis VautrinVandoeuvre les nancyFrance54519

Sponsors and Collaborators

  • Centre Leon Berard

Investigators

  • Principal Investigator: Gisèle CHVETZOFF, MD, Centre Leon Berard

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT04459234
Other Study ID Numbers:
  • ET20-130 - KETACANCER
First Posted:
Jul 7, 2020
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Leon Berard
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021