Vulnerability and Risk of Neuropathic Pain in Cancer (CANOPY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Neuropathic Pain; Predictive
• Intervention / Treatment: Other: Cognitive-emotional and pain assessments

• Study Type: Interventional
• Enrollment (Estimated): 625
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise LACLAUTRE; Phone Number: +33 473754963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Ajaccio, France, 20000
    • Recruiting
    • Centre Hospitalier d'Ajaccio
    • Principal Investigator: Daniel Nicolas
  • Angers, France, 49100
    • Recruiting
    • Centre de Lutte contre le Cancer - Institut de Cancérologie de l'Ouest
    • Principal Investigator: Sabrina Jubier Hamon
  • Aurillac, France, 15000
    • Recruiting
    • Centre Hospitalier Henri Mondor d'Aurillac
    • Principal Investigator: Daniela BURLACU
  • Bordeaux, France, 33000
    • Recruiting
    • Centre de Lutte Contre le Cancer - Institut Bergonie
    • Principal Investigator: Mickaël Desroches
    • Principal Investigator: Laurent Labreze
  • Caen, France, 14000
    • Recruiting
    • Centre de Lutte contre le Cancer - Centre François Baclesse
    • Principal Investigator: Lauriane FOUREL
    • Principal Investigator: Frédérique Bisiaux
    • Principal Investigator: Franck Le Caer
  • Caen, France, 14000
    • Recruiting
    • Centre Hospitalier Universitaire Caen Normandie
    • Principal Investigator: Cyril Guillaumé
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Gisèle PICKERING
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • Centre de Lutte contre le Cancer - Jean Perrin
    • Principal Investigator: Christine Villatte
  • Colmar, France, 68024
    • Recruiting
    • Hôpitaux Civils de Colmar
    • Principal Investigator: Erwan Treillet
  • Dijon, France, 21079
    • Recruiting
    • Centre Régional de Lutte contre le Cancer - Georges Francois Leclerc
    • Principal Investigator: Christian Minello
  • Lille, France, 59000
    • Recruiting
    • Hôpital Privé Le Bois
    • Principal Investigator: Romain Chiquet
  • Montluçon, France, 03100
    • Not yet recruiting
    • Centre Hospitalier de Montluçon
    • Principal Investigator: Orianne DELEPINE
  • Moulins, France, 03000
    • Recruiting
    • Centre Hospitalier de Moulins-Yzeure
    • Principal Investigator: Michael Azagury
  • Paris, France, 75010
    • Recruiting
    • Hôpital Saint-Louis APHP
    • Principal Investigator: Anne Blazy
  • Paris, France, 92110
    • Recruiting
    • Hôpital Beaujon AP-HP
    • Principal Investigator: Bruno Vincent
  • Reims, France
    • Recruiting
    • Institut Godinot
    • Principal Investigator: Grégoire OUDOT
  • Saint-Brieuc, France
    • Recruiting
    • Centre Hospitalier Yves Le Foll
    • Principal Investigator: Homauon ALIPOUR
    • Principal Investigator: Sylvain Lecoeur
  • Valenciennes, France
    • Recruiting
    • Ch Valenciennes
    • Principal Investigator: Antoine LEMAIRE
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy
    • Principal Investigator: Rita Kortbaoui

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: Cognitive-emotional and pain assessments; Data collection on cognitive-emotional and pain parameters using questionnaires.
Experimental: Healthy volunteers controls; 125 healthy control volunteers from the volunteer database	Other: Cognitive-emotional and pain assessments; Data collection on cognitive-emotional and pain parameters using questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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)	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.	Baseline
Pain assessment using the Numerical Pain Scale (EN)	Numerical Pain Scale (EN): This numerical scale provides a pain assessment from 0 to 10.	6 months
Pain assessment using the Neuropathic Pain Questionnaire (DN4)	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.	6 months
Pain assessment using the Numerical Pain Scale (EN)	Numerical Pain Scale (EN): This numerical scale provides a pain assessment from 0 to 10.	12 months
Pain assessment using the Neuropathic Pain Questionnaire (DN4)	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.	12 months
Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire	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.	Baseline
Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire	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.	6 months
Assessment of cognitive status using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG) questionnaire	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.	12 months
Assessment of emotional status using the Anxiety and Depression Scale (HAD)	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.	Baseline
Assessment of emotional status using the Anxiety and Depression Scale (HAD)	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.	6 months
Assessment of emotional status using the Anxiety and Depression Scale (HAD)	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 months
Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)	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.	Baseline
Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)	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.	6 months
Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)	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.	12 months
Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)	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.	Baseline
Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)	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.	Baseline
Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)	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.	6 months
Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)	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.	6 months
Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)	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.	12 months
Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)	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.	12 months
Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)	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.	Baseline
Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)	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.	Baseline
Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)	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.	6 months
Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)	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.	6 months
Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)	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.	12 months
Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)	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.	12 months
Assessment of analgesic consumption	Assessment of analgesic consumption throughout the study.	Baseline
Assessment of analgesic consumption	Assessment of analgesic consumption throughout the study.	6 months
Assessment of analgesic consumption	Assessment of analgesic consumption throughout the study.	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Neuralgia
• Other Study ID Numbers: RBHP 2023 PICKERING

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No