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

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ClinicalTrials.gov Identifier: NCT04459234
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Tracking Information
First Submitted Date July 1, 2020
First Posted Date July 7, 2020
Last Update Posted Date March 15, 2022
Actual Study Start Date February 2, 2021
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2020)
  • Describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of indication [ Time Frame: 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 [ Time Frame: Up to 3 months after inclusion ]
    route, posology, duration, administration sequence, premedication
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 7, 2020)
  • Evaluate in the context of cancer the antalgic efficacy [ Time Frame: Up to 3 months after inclusion ]
    Questionnaire: NPSI
  • Evaluate in the context of cancer the antalgic efficacy [ Time Frame: Up to 3 months after inclusion ]
    Questionnaire: DN4
  • Evaluate in the context of cancer the antalgic efficacy [ Time Frame: Up to 3 months after inclusion ]
    Questionnaire: PGIC
  • Evaluate in the context of cancer the tolerance profile [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 3 months after inclusion ]
    Questionnaire: HADS
Original Secondary Outcome Measures
 (submitted: July 1, 2020)
  • Evaluate in the context of cancer the antalgic efficacy [ Time Frame: Up to 3 months after inclusion ]
    Questionnaires: NPSI, DN4 and PGIC
  • Evaluate in the context of cancer the tolerance profile [ Time Frame: Up to 3 months after inclusion ]
    Biological and clinical toxicities
  • Evaluate in the context of cancer the quality of life including anxiety and depression [ Time Frame: Up to 3 months after inclusion ]
    Visual analogic scale and HADS
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Multicentre Study of the Use of Ketamine in the Treatment of Refractory Chronic Pain in the French CLCC
Official Title KETACANCER: Prospective Multicentre Study of the Use of Ketamine in the Treatment of Refractory Chronic Pain in the French CLCC
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Cancer
  • Chronic Pain
  • Neuropathic Pain
  • Opioid Use
Intervention Drug: 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 14, 2022)
150
Original Estimated Enrollment
 (submitted: July 1, 2020)
183
Estimated Study Completion Date March 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Julien GAUTIER +33 4.26.55.68.29 julien.gautier@lyon.unicancer.fr
Contact: Gisèle CHVETZOFF, MD +33 4.78.78.26.57 gisele.chvetzoff@lyon.unicancer.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04459234
Other Study ID Numbers ET20-130 - KETACANCER
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Centre Leon Berard
Original Responsible Party Same as current
Current Study Sponsor Centre Leon Berard
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Gisèle CHVETZOFF, MD Centre Leon Berard
PRS Account Centre Leon Berard
Verification Date March 2022