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NCT Number: NCT06511674

Vulnerability and Risk of Neuropathic Pain in Cancer

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.

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Key information

Conditions

Neuropathic Pain Cancer Neoplasms Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Predictive Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier d'Ajaccio, Ajaccio, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive-emotional and pain assessments

Other

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

Primary outcomes

  1. CANoPy score (Z-score)

    Time frame: Baseline

    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.

  2. CANoPy score (Z-score)

    Time frame: 6 months

    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.

  3. CANoPy score (Z-score)

    Time frame: 12 months

    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.

Secondary outcomes

  1. Pain assessment using the Numerical Pain Scale (EN)

    Time frame: Baseline

    Numerical Pain Scale (EN): This numerical scale provides a pain assessment from 0 to 10.

  2. Pain assessment using the Neuropathic Pain Questionnaire (DN4)

    Time frame: Baseline

    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.

  3. Pain assessment using the Numerical Pain Scale (EN)

    Time frame: 6 months

    Numerical Pain Scale (EN): This numerical scale provides a pain assessment from 0 to 10.

  4. Pain assessment using the Neuropathic Pain Questionnaire (DN4)

    Time frame: 6 months

    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.

  5. Pain assessment using the Numerical Pain Scale (EN)

    Time frame: 12 months

    Numerical Pain Scale (EN): This numerical scale provides a pain assessment from 0 to 10.

  6. Pain assessment using the Neuropathic Pain Questionnaire (DN4)

    Time frame: 12 months

    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.

  7. Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire

    Time frame: Baseline

    Functional Assessment of Cancer Therapy COGnitive function (FACT-COG): The Functional Assessment of Cancer Therapy-COGnitive function, known as FACT-COG, is a 37-item self-report questionnaire of perceived cognitive impairment. It assesses mental acuity, attention and concentration, memory, verbal fluency, functional interference, deficits observed by others, changes from previous functioning and impact on quality of life. These items were developed on the basis of interviews with cancer patients and their carers. The FACT-COG has been validated in a study of cancer patients.

  8. Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire

    Time frame: 6 months

    Functional Assessment of Cancer Therapy COGnitive function (FACT-COG): The Functional Assessment of Cancer Therapy-COGnitive function, known as FACT-COG, is a 37-item self-report questionnaire of perceived cognitive impairment. It assesses mental acuity, attention and concentration, memory, verbal fluency, functional interference, deficits observed by others, changes from previous functioning and impact on quality of life. These items were developed on the basis of interviews with cancer patients and their carers. The FACT-COG has been validated in a study of cancer patients.

  9. Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire

    Time frame: 12 months

    Functional Assessment of Cancer Therapy COGnitive function (FACT-COG): The Functional Assessment of Cancer Therapy-COGnitive function, known as FACT-COG, is a 37-item self-report questionnaire of perceived cognitive impairment. It assesses mental acuity, attention and concentration, memory, verbal fluency, functional interference, deficits observed by others, changes from previous functioning and impact on quality of life. These items were developed on the basis of interviews with cancer patients and their carers. The FACT-COG has been validated in a study of cancer patients.

  10. Assessment of emotional status using the Anxiety and Depression Scale (HAD)

    Time frame: Baseline

    The Hospital Anxiety Depression (HAD) scale is a 14-item self-administered questionnaire completed by the patient. These items are divided into two subscales: 7 items to assess depression and 7 items to assess anxiety.

  11. Assessment of emotional status using the Anxiety and Depression Scale (HAD)

    Time frame: 6 months

    The Hospital Anxiety Depression (HAD) scale is a 14-item self-administered questionnaire completed by the patient. These items are divided into two subscales: 7 items to assess depression and 7 items to assess anxiety.

  12. Assessment of emotional status using the Anxiety and Depression Scale (HAD)

    Time frame: 12 months

    The Hospital Anxiety Depression (HAD) scale is a 14-item self-administered questionnaire completed by the patient. These items are divided into two subscales: 7 items to assess depression and 7 items to assess anxiety.

  13. Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)

    Time frame: Baseline

    The Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES) questionnaire consists of 11 binary questions (yes/no) used to calculate an individual score indicating precariousness and health inequalities ranging from 0 to 100.

  14. Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)

    Time frame: 6 months

    The Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES) questionnaire consists of 11 binary questions (yes/no) used to calculate an individual score indicating precariousness and health inequalities ranging from 0 to 100.

  15. Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)

    Time frame: 12 months

    The Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES) questionnaire consists of 11 binary questions (yes/no) used to calculate an individual score indicating precariousness and health inequalities ranging from 0 to 100.

  16. Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)

    Time frame: Baseline

    EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) : The self-reported EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) is used as a tool to measure the (health-related) quality of life of cancer patients. This tool is used to assess their own level of functioning in different areas of quality of life.The questionnaire comprises 9 subscales, each consisting of several items: 5 subscales measuring functional status, 3 symptom subscales, and an overall subscale measuring quality of life and state of health.

  17. Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline

    Pittsburg Sleep Quality Index (PSQI): The Pittsburg Sleep Quality Index (PSQI) is a self-administered questionnaire comprising 19 items. It was developed to measure sleep quality in the month preceding the patient interview. The questionnaire has 7 components: subjective sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disturbance, use of sleep medication and poor daytime sleepiness.

  18. Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)

    Time frame: 6 months

    EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) : The self-reported EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) is used as a tool to measure the (health-related) quality of life of cancer patients. This tool is used to assess their own level of functioning in different areas of quality of life.The questionnaire comprises 9 subscales, each consisting of several items: 5 subscales measuring functional status, 3 symptom subscales, and an overall subscale measuring quality of life and state of health.

  19. Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 6 months

    Pittsburg Sleep Quality Index (PSQI): The Pittsburg Sleep Quality Index (PSQI) is a self-administered questionnaire comprising 19 items. It was developed to measure sleep quality in the month preceding the patient interview. The questionnaire has 7 components: subjective sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disturbance, use of sleep medication and poor daytime sleepiness.

  20. Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)

    Time frame: 12 months

    EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) : The self-reported EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) is used as a tool to measure the (health-related) quality of life of cancer patients. This tool is used to assess their own level of functioning in different areas of quality of life.The questionnaire comprises 9 subscales, each consisting of several items: 5 subscales measuring functional status, 3 symptom subscales, and an overall subscale measuring quality of life and state of health.

  21. Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 12 months

    Pittsburg Sleep Quality Index (PSQI): The Pittsburg Sleep Quality Index (PSQI) is a self-administered questionnaire comprising 19 items. It was developed to measure sleep quality in the month preceding the patient interview. The questionnaire has 7 components: subjective sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disturbance, use of sleep medication and poor daytime sleepiness.

  22. Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)

    Time frame: Baseline

    Illness Perception Questionnaire Revised (IPQ-R): The Illness Perception Questionnaire Revised (IPQ-R) is a self-administered questionnaire which assesses representations of the illness. It consists of 70 items divided into three categories: vision of the illness, point of view of the illness and causes of the illness.

  23. Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)

    Time frame: Baseline

    Cancer Locus of Control Scale (CLCS): This 17-item disease-specific controllability scale has been validated in a French population of breast cancer patients and is used to measure the perception of control over serious chronic illness and cancer. The items are rated using a four-point Likert scale (from 1 "strongly disagree" to 4 "strongly agree"). The items are divided into three subscales: perceived control over the course of the disease, internal causal attribution, and religious control.

  24. Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)

    Time frame: 6 months

    Illness Perception Questionnaire Revised (IPQ-R): The Illness Perception Questionnaire Revised (IPQ-R) is a self-administered questionnaire which assesses representations of the illness. It consists of 70 items divided into three categories: vision of the illness, point of view of the illness and causes of the illness.

  25. Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)

    Time frame: 6 months

    Cancer Locus of Control Scale (CLCS): This 17-item disease-specific controllability scale has been validated in a French population of breast cancer patients and is used to measure the perception of control over serious chronic illness and cancer. The items are rated using a four-point Likert scale (from 1 "strongly disagree" to 4 "strongly agree"). The items are divided into three subscales: perceived control over the course of the disease, internal causal attribution, and religious control.

  26. Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)

    Time frame: 12 months

    Illness Perception Questionnaire Revised (IPQ-R): The Illness Perception Questionnaire Revised (IPQ-R) is a self-administered questionnaire which assesses representations of the illness. It consists of 70 items divided into three categories: vision of the illness, point of view of the illness and causes of the illness.

  27. Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)

    Time frame: 12 months

    Cancer Locus of Control Scale (CLCS): This 17-item disease-specific controllability scale has been validated in a French population of breast cancer patients and is used to measure the perception of control over serious chronic illness and cancer. The items are rated using a four-point Likert scale (from 1 "strongly disagree" to 4 "strongly agree"). The items are divided into three subscales: perceived control over the course of the disease, internal causal attribution, and religious control.

  28. Assessment of analgesic consumption

    Time frame: Baseline

    Assessment of analgesic consumption throughout the study.

  29. Assessment of analgesic consumption

    Time frame: 6 months

    Assessment of analgesic consumption throughout the study.

  30. Assessment of analgesic consumption

    Time frame: 12 months

    Assessment of analgesic consumption throughout the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Lise LACLAUTRE

CONTACT

[email protected]

473754963 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: CANOPY

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 22, 2024
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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