Study Results
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Basic Information
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RECRUITING
NA
625 participants
INTERVENTIONAL
2024-10-28
2028-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Cancer patients
500 cancer patients: 100 women with breast cancer, 100 women with gynecological cancer, 150 patients with lung cancer (100 men, 50 women) and 150 patients with colorectal cancer (100 men, 50 women).
Cognitive-emotional and pain assessments
Data collection on cognitive-emotional and pain parameters using questionnaires.
Healthy volunteers controls
125 healthy control volunteers from the volunteer database
Cognitive-emotional and pain assessments
Data collection on cognitive-emotional and pain parameters using questionnaires.
Interventions
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Cognitive-emotional and pain assessments
Data collection on cognitive-emotional and pain parameters using questionnaires.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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RBHP 2023 PICKERING
Identifier Type: -
Identifier Source: org_study_id
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