Clinical trial NCT06511674: Vulnerability and Risk of Neuropathic Pain in Cancer
Official title: Vulnerability and Risk of Neuropathic Pain in Cancer: Validation of a Predictive Tool to Optimize Treatment.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuropathic Pain
Cancer
Predictive
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 625
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Primary outcomes:
measure: CANoPy score (Z-score)
timeFrame: Baseline
measure: CANoPy score (Z-score)
timeFrame: 6 months
measure: CANoPy score (Z-score)
timeFrame: 12 months
Secondary outcomes:
measure: Pain assessment using the Numerical Pain Scale (EN)
timeFrame: Baseline
measure: Pain assessment using the Neuropathic Pain Questionnaire (DN4)
timeFrame: Baseline
measure: Pain assessment using the Numerical Pain Scale (EN)
timeFrame: 6 months
measure: Pain assessment using the Neuropathic Pain Questionnaire (DN4)
timeFrame: 6 months
measure: Pain assessment using the Numerical Pain Scale (EN)
timeFrame: 12 months
measure: Pain assessment using the Neuropathic Pain Questionnaire (DN4)
timeFrame: 12 months
measure: Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire
timeFrame: Baseline
measure: Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire
timeFrame: 6 months
measure: Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire
timeFrame: 12 months
measure: Assessment of emotional status using the Anxiety and Depression Scale (HAD)
timeFrame: Baseline
measure: Assessment of emotional status using the Anxiety and Depression Scale (HAD)
timeFrame: 6 months
measure: Assessment of emotional status using the Anxiety and Depression Scale (HAD)
timeFrame: 12 months
measure: Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)
timeFrame: Baseline
measure: Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)
timeFrame: 6 months
measure: Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)
timeFrame: 12 months
measure: Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Baseline
measure: Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: 6 months
measure: Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 months
measure: Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: 12 months
measure: Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12 months
measure: Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)
timeFrame: Baseline
measure: Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)
timeFrame: Baseline
measure: Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)
timeFrame: 6 months
measure: Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)
timeFrame: 6 months
measure: Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)
timeFrame: 12 months
measure: Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)
timeFrame: 12 months
measure: Assessment of analgesic consumption
timeFrame: Baseline
measure: Assessment of analgesic consumption
timeFrame: 6 months
measure: Assessment of analgesic consumption
timeFrame: 12 months
Other outcomes:
Locations:
city: Ajaccio
country: France
facility: Centre Hospitalier d'Ajaccio
city: Angers
country: France
facility: Centre de Lutte contre le Cancer - Institut de Cancérologie de l'Ouest
city: Aurillac
country: France
facility: Centre Hospitalier Henri Mondor d'Aurillac
city: Bordeaux
country: France
facility: Centre de Lutte contre le Cancer - Institut Bergonié
city: Caen
country: France
facility: Centre de Lutte contre le Cancer - Centre François Baclesse
city: Caen
country: France
facility: Centre Hospitalier Universitaire Caen Normandie
city: Clermont-Ferrand
country: France
facility: Centre de Lutte contre le Cancer - Jean Perrin
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Colmar
country: France
facility: Hôpitaux civils de Colmar
city: Dijon
country: France
facility: Centre Régional de Lutte contre le Cancer - Georges Francois Leclerc
city: Lille
country: France
facility: Hôpital privé le Bois
city: Moulins
country: France
facility: Centre Hospitalier de Moulins-Yzeure
city: Paris
country: France
facility: Hôpital Saint-Louis APHP
city: Paris
country: France
facility: Hôpital Beaujon AP-HP
city: Reims
country: France
facility: Institut Godinot
city: Saint Brieuc
country: France
facility: Centre Hospitalier Yves Le Foll
city: Valenciennes
country: France
facility: CH Valenciennes
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: