Neuropathic PainCANOPYNCT06511674
Vulnerability and Risk of Neuropathic Pain in Cancer
A study testing Cognitive-emotional and pain assessments in people with Neuropathic Pain and Cancer, run by University Hospital, Clermont-Ferrand at 19 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain, Cancer, Predictive
- What is being tested?
- Cognitive-emotional and pain assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- 19 sitesFrance
- Study dates
- 28 Oct 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Subject over 18 years of age,
Show all 12Show fewer
- 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,
Who cannot join
- 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,
Show all 12Show fewer
- Beneficiary of a legal protection measure.
- 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.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
France19 sites, 19 recruiting
- Recruiting
Centre Hospitalier d'Ajaccio
Ajaccio, 20000
Daniel Nicolas
- Recruiting
Centre de Lutte contre le Cancer - Institut de Cancérologie de l'Ouest
Angers, 49100
Sabrina Jubier Hamon
- Recruiting
Centre Hospitalier Henri Mondor d'Aurillac
Aurillac, 15000
Daniela Burlacu
- Recruiting
Centre de Lutte contre le Cancer - Institut Bergonié
Bordeaux, 33000
Mickaël Desroches
Laurent Labreze
- Recruiting
Centre de Lutte contre le Cancer - Centre François Baclesse
Caen, 14000
Franck Le Caer
Lauriane Fourel
- Recruiting
Centre Hospitalier Universitaire Caen Normandie
Caen, 14000
Cyril Guillaumé
- Recruiting
Centre de Lutte contre le Cancer - Jean Perrin
Clermont-Ferrand, 63000
Christine Villatte
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Gisèle Pickering
- Recruiting
Hôpitaux civils de Colmar
Colmar, 68024
Erwan Treillet
- Recruiting
Centre Régional de Lutte contre le Cancer - Georges Francois Leclerc
Dijon, 21079
Christian Minello
- Recruiting
Hôpital privé le Bois
Lille, 59000
Romain Chiquet
- Not yet recruiting
Centre Hospitalier de Montluçon
Montluçon, 03100
Orianne DELEPINE
- Recruiting
Centre Hospitalier de Moulins-Yzeure
Moulins, 03000
Michael Azagury
- Recruiting
Hôpital Saint-Louis APHP
Paris, 75010
Anne Blazy
- Recruiting
Hôpital Beaujon AP-HP
Paris, 92110
Bruno Vincent
- Recruiting
Institut Godinot
Reims
Grégoire OUDOT
- Recruiting
Centre Hospitalier Yves Le Foll
Saint-Brieuc
Homauon ALIPOUR
Sylvain Lecoeur
- Recruiting
CH Valenciennes
Valenciennes
Antoine LEMAIRE
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Rita Kortbaoui
About this study
Official title: 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.
- Conditions
- Neuropathic Pain, Cancer, Predictive
- Being tested
- Cognitive-emotional and pain assessments
- Medical subject headings
- Neuralgia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-emotional and pain assessmentsOther
Data collection on cognitive-emotional and pain parameters using questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Cognitive-emotional and pain assessments |
| Healthy volunteers controls | Experimental | 125 healthy control volunteers from the volunteer database Receives: Other: Cognitive-emotional and pain assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (30)
Pain assessment using the Numerical Pain Scale (EN)
Numerical Pain Scale (EN): This numerical scale provides a pain assessment from 0 to 10.
Measured: 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.
Measured: Baseline
Pain assessment using the Numerical Pain Scale (EN)
Numerical Pain Scale (EN): This numerical scale provides a pain assessment from 0 to 10.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Assessment of analgesic consumption
Assessment of analgesic consumption throughout the study.
Measured: Baseline
Assessment of analgesic consumption
Assessment of analgesic consumption throughout the study.
Measured: 6 months
Assessment of analgesic consumption
Assessment of analgesic consumption throughout the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start28 Oct 2024
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511674
- Sponsor's protocol ID
- RBHP 2023 PICKERING
- Acronym
- CANOPY
- Status last verified
- Jun 2025
- First submitted
- 4 Jul 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vulnerability and Risk of Neuropathic Pain in Cancer: Validation of a Predictive Tool to Optimize Treatment.
- ClinicalTrials.gov ID
- NCT06511674
- Acronym / sponsor ID
- CANOPY / RBHP 2023 PICKERING
- Conditions
- Neuropathic Pain, Cancer, Predictive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | Experimental | Other: Cognitive-emotional and pain assessments500 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). |
| Healthy volunteers controls | Experimental | Other: Cognitive-emotional and pain assessments125 healthy control volunteers from the volunteer database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-emotional and pain assessmentsData collection on cognitive-emotional and pain parameters using questionnaires. | Other | Cancer patients, Healthy volunteers controls |
Primary outcome
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.
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.
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.
30 secondary outcomes
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
Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)
Time frame: Baseline
Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)
Time frame: 6 months
Evaluation of social vulnerability using the questionnaire Evaluation of Deprivation and Inequalities in Health Examination Centres (EPICES)
Time frame: 12 months
Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: Baseline
Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: 6 months
Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 months
Assessment of quality of life using the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: 12 months
Assessment of quality of sleep using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 months
Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)
Time frame: Baseline
Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)
Time frame: Baseline
Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)
Time frame: 6 months
Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)
Time frame: 6 months
Assessment of disease perception and beliefs using the Illness Perception Questionnaire Revised (IPQ-R)
Time frame: 12 months
Assessment of disease perception and beliefs using the disease-specific Cancer Locus of Control Scale (CLCS)
Time frame: 12 months
Assessment of analgesic consumption
Time frame: Baseline
Assessment of analgesic consumption
Time frame: 6 months
Assessment of analgesic consumption
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-emotional and pain assessments in people with Neuropathic Pain and Cancer, run by University Hospital, Clermont-Ferrand at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (473754963 ext. +33, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CANoPy score (Z-score) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.