Informations générales (source: ClinicalTrials.gov)

NCT06511674 En recrutement IDF
Vulnerability and Risk of Neuropathic Pain in Cancer: Validation of a Predictive Tool to Optimize Treatment.
Interventional
  • Névralgie
N/A
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
octobre 2024
juin 2028
15 septembre 2025
Successive and repeated therapeutic interventions during cancer management - surgery, chemotherapy, radiotherapy - can all, to varying degrees, generate acute pain, central pain sensitization and chronic pain. Almost 58% of patients suffer from chronic pain, often of the neuropathic type, with altered quality of life and disease burden amplified by difficulty in achieving effective relief. Indeed, neuropathic pain in cancer remains difficult to treat, often arrives insidiously, may persist well beyond cancer remission, and frequently has a fate that is difficult to predict. Current treatments for neuropathic pain are based on the recommendations of learned societies, but therapeutic failures are frequent, and iatrogenic pathology is high. Many factors have been identified as being associated with the development of chronic pain in cancer patients. The intensity of preoperative pain, opioid consumption, age, sleep disorders, cognitive-emotional state, psychological vulnerability and social precariousness are all factors that influence and perpetuate chronic pain linked to cancer and its management. Several studies have shown that 6 months or 1 year after cancer diagnosis, there are various pain trajectories, enabling us to identify several pain patient phenotypes. The patient's overall state of vulnerability at the time of cancer diagnosis has an impact on the trajectory of pain chronicisation, and it is often difficult for clinicians to apprehend this risk. In practice, we lack a validated, easy-to-use tool that would enable us to predict the risk of pain chronicisation for each patient, even before the start of the treatment process.

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Beaujon En recrutement IDF Contact (sur clinicalTrials)
CLCC INSTITUT GUSTAVE ROUSSY En recrutement IDF Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre de Lutte contre le Cancer - Centre François Baclesse - 14000 - Caen - France En recrutement Contact (sur clinicalTrials)
Centre de Lutte contre le Cancer - Institut Bergonié - 33000 - Bordeaux - France En recrutement Contact (sur clinicalTrials)
Centre de Lutte contre le Cancer - Institut de Cancérologie de l'Ouest - 49100 - Angers - France En recrutement Contact (sur clinicalTrials)
Centre de Lutte contre le Cancer - Jean Perrin - 63000 - Clermont-Ferrand - France En recrutement Contact (sur clinicalTrials)
Centre Hospitalier d'Ajaccio - 20000 - Ajaccio - France En recrutement Contact (sur clinicalTrials)
Centre Hospitalier de Moulins-Yzeure - 03000 - Moulins - France En recrutement Contact (sur clinicalTrials)
Centre Hospitalier Henri Mondor d'Aurillac - 15000 - Aurillac - France En recrutement Contact (sur clinicalTrials)
Centre Hospitalier Universitaire Caen Normandie - 14000 - Caen - France En recrutement Contact (sur clinicalTrials)
Centre Hospitalier Yves Le Foll - Saint Brieuc - France En recrutement Contact (sur clinicalTrials)
Centre Régional de Lutte contre le Cancer - Georges Francois Leclerc - 21079 - Dijon - France En recrutement Contact (sur clinicalTrials)
CH Valenciennes - Valenciennes - France En recrutement Contact (sur clinicalTrials)
CHU de Clermont-Ferrand - 63000 - Clermont-Ferrand - France En recrutement Contact (sur clinicalTrials)
Hôpital privé le Bois - 59000 - Lille - France En recrutement Contact (sur clinicalTrials)
Hôpital Saint-Louis APHP - 75010 - Paris - France En recrutement Contact (sur clinicalTrials)
Hôpitaux civils de Colmar - 68024 - Colmar - France En recrutement Contact (sur clinicalTrials)
Institut Godinot - Reims - France En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria Patients:

- Patient over 18 years of age,

- Patient suffering from cancer (breast, gynecological, colorectal, lung) and having
to undergo one or more anti-cancer therapeutic procedures (chemotherapy, surgery,
hormonal therapy, radiotherapy, targeted therapy, etc.),

- Sufficient cooperation and understanding to comply with the study requirements,

- Agreement to give oral consent for the study,

- Affiliation with the French Social Security system.

Exclusion Criteria Patients:

- History of cancer and anti-cancer therapy (surgery, chemotherapy, radiotherapy,
hormone therapy, targeted therapy, etc.),

- History and/or presence of primary brain tumors (glioblastoma, meningioma,
neurofibroma, etc.) ),

- History of neurological disorders (Parkinson's disease, Alzheimer's disease,
dementia, epilepsy, moderate to severe head trauma, etc.),

- Medical and/or surgical history judged by the investigator or his representative to
be incompatible with the study,

- Subject whose cooperation and understanding do not allow strict compliance with the
conditions laid down in the protocol,

- Pregnant or breast-feeding women,

- Beneficiary of a legal protection measure.

Inclusion Criteria Healthy Volunteers:

- Subject over 18 years of age,

- Subject free of any treatment in the 7 days preceding inclusion, in particular no
use of analgesics, or judged by the investigator or his representative to be
compatible with the study

- Subject with no history of cancer,

- Subject considered to be in good health by the investigator,

- Sufficient cooperation and understanding to comply with the study requirements,

- Agreement to give oral consent to the study,

- Affiliation with the French Social Security system,

Exclusion Criteria Healthy Volunteers:

- Subjects with a medical and/or surgical history judged by the investigator or his
representative to be incompatible with the trial,

- Subjects whose cooperation and understanding do not allow strict compliance with the
conditions laid down in the protocol,

- Pregnant or breast-feeding woman,

- Participating in another clinical trial, or within the exclusion period, or having
received a total amount of compensation exceeding 4500 euros over the 12 months
preceding the start of the trial,

- Benefiting from a legal protection measure.