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.

Overview

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.

Interventions

• Other Cognitive-emotional and pain assessments
  Data collection on cognitive-emotional and pain parameters using questionnaires.

Primary outcome measures

• CANoPy score (Z-score) [Time frame: Baseline]
• CANoPy score (Z-score) [Time frame: 6 months]
• CANoPy score (Z-score) [Time frame: 12 months]

Secondary outcome measures (12)

• Pain assessment using the Numerical Pain Scale (EN) [Time frame: Baseline]
• Pain assessment using the Neuropathic Pain Questionnaire (DN4) [Time frame: Baseline]
• Pain assessment using the Numerical Pain Scale (EN) [Time frame: 6 months]
• Pain assessment using the Neuropathic Pain Questionnaire (DN4) [Time frame: 6 months]
• Pain assessment using the Numerical Pain Scale (EN) [Time frame: 12 months]
• Pain assessment using the Neuropathic Pain Questionnaire (DN4) [Time frame: 12 months]
• Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire [Time frame: Baseline]
• Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire [Time frame: 6 months]
• Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire [Time frame: 12 months]
• Assessment of emotional status using the Anxiety and Depression Scale (HAD) [Time frame: Baseline]
• Assessment of emotional status using the Anxiety and Depression Scale (HAD) [Time frame: 6 months]
• Assessment of emotional status using the Anxiety and Depression Scale (HAD) [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

France · 19 centers

• Centre Hospitalier d'Ajaccio — Ajaccio
• Centre de Lutte contre le Cancer - Institut de Cancérologie de l'Ouest — Angers
• Centre Hospitalier Henri Mondor d'Aurillac — Aurillac
• Centre de Lutte contre le Cancer - Institut Bergonié — Bordeaux
• Centre de Lutte contre le Cancer - Centre François Baclesse — Caen
• Centre Hospitalier Universitaire Caen Normandie — Caen
• Centre de Lutte contre le Cancer - Jean Perrin — Clermont-Ferrand
• CHU de Clermont-Ferrand — Clermont-Ferrand
• … and 11 more centers

Identifiers

NCT: NCT06511674 · RBHP 2023 PICKERING

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗