Vulnerability and Risk of Neuropathic Pain in Cancer | NCT06511674

NCT06511674

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cancer patients	Experimental	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).	Other: Cognitive-emotional and pain assessments
Healthy volunteers controls	Experimental	125 healthy control volunteers from the volunteer database	Other: Cognitive-emotional and pain assessments

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive-emotional and pain assessments	Other	Data collection on cognitive-emotional and pain parameters using questionnaires.	Cancer patients Healthy volunteers controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CANoPy score (Z-score)	Calculation of the CANoPy score (Z-score) predictive of the development of neuropathic pain. The z-scores are then averaged across endpoints for each patient.	Baseline
CANoPy score (Z-score)	Calculation of the CANoPy score (Z-score) predictive of the development of neuropathic pain. The z-scores are then averaged across endpoints for each patient.	6 months
CANoPy score (Z-score)	Calculation of the CANoPy score (Z-score) predictive of the development of neuropathic pain. The z-scores are then averaged across endpoints for each patient.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Pain assessment using the Numerical Pain Scale (EN)	Numerical Pain Scale (EN): This numerical scale provides a pain assessment from 0 to 10.	Baseline
Pain assessment using the Neuropathic Pain Questionnaire (DN4)

Eligibility Module

Eligibility Criteria

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.

Name	Role	Phone	Extension	Email
Lise LACLAUTRE	Contact	473754963	+33	promo_interne_drci@chu-clermontferrand.fr

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier d'Ajaccio	Recruiting	Ajaccio		20000	France

ID	Term
D009437	Neuralgia
D009369	Neoplasms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

Neuropathic Pain (DN4): This questionnaire estimates the probability of neuropathic pain in a patient, by means of four questions divided into ten items to be ticked. The practitioner or clinical research associate in charge of the study interviews or examines the patient and fills in the questionnaire himself. Each item is marked with a "yes" or "no" answer. Each "yes" is worth a score of 1, and each "no" is worth a score of 0. The sum of the scores gives the patient's score (out of 10); if the patient's score is equal to or greater than 4/10, the test is positive.