RecruitingNot ApplicableNCT06511674

Vulnerability and Risk of Neuropathic Pain in Cancer

Vulnerability and Risk of Neuropathic Pain in Cancer: Validation of a Predictive Tool to Optimize Treatment.


Sponsor

University Hospital, Clermont-Ferrand

Enrollment

625 participants

Start Date

Oct 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria12

  • 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.
  • 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 Criteria12

  • 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.
  • 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.

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Interventions

OTHERCognitive-emotional and pain assessments

Data collection on cognitive-emotional and pain parameters using questionnaires.


Locations(19)

Centre Hospitalier d'Ajaccio

Ajaccio, France

Centre de Lutte contre le Cancer - Institut de Cancérologie de l'Ouest

Angers, France

Centre Hospitalier Henri Mondor d'Aurillac

Aurillac, France

Centre de Lutte contre le Cancer - Institut Bergonié

Bordeaux, France

Centre de Lutte contre le Cancer - Centre François Baclesse

Caen, France

Centre Hospitalier Universitaire Caen Normandie

Caen, France

Centre de Lutte contre le Cancer - Jean Perrin

Clermont-Ferrand, France

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Hôpitaux civils de Colmar

Colmar, France

Centre Régional de Lutte contre le Cancer - Georges Francois Leclerc

Dijon, France

Hôpital privé le Bois

Lille, France

Centre Hospitalier de Montluçon

Montluçon, France

Centre Hospitalier de Moulins-Yzeure

Moulins, France

Hôpital Saint-Louis APHP

Paris, France

Hôpital Beaujon AP-HP

Paris, France

Institut Godinot

Reims, France

Centre Hospitalier Yves Le Foll

Saint-Brieuc, France

CH Valenciennes

Valenciennes, France

Institut Gustave Roussy

Villejuif, France

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NCT06511674


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