Vulnerability and Risk of Neuropathic Pain in Cancer

NCT06511674 | Recruiting

• 1 other identifier: RBHP 2023 PICKERING
• Study Type: interventional
• Target: 625
• Locations: 1 country
• Sites: 19

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.

Conditions

Neuropathic Pain; Cancer; Predictive

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (30)

• Pain assessment using the Numerical Pain Scale (EN)

  Baseline

• Pain assessment using the Neuropathic Pain Questionnaire (DN4)

  Baseline

• Pain assessment using the Numerical Pain Scale (EN)

  6 months

• Pain assessment using the Neuropathic Pain Questionnaire (DN4)

  6 months

• Pain assessment using the Numerical Pain Scale (EN)

  12 months

Study Arms (2)

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).

Other: Cognitive-emotional and pain assessments

Healthy volunteers controls

EXPERIMENTAL

125 healthy control volunteers from the volunteer database

Other: Cognitive-emotional and pain assessments

Interventions

Cognitive-emotional and pain assessments OTHER

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

Cancer patients; Healthy volunteers controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subject over 18 years of age,
• 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,
• 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,

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (19)

Centre Hospitalier d'Ajaccio

Ajaccio, 20000, France

RECRUITING

Centre de Lutte contre le Cancer - Institut de Cancérologie de l'Ouest

Angers, 49100, France

RECRUITING

Centre Hospitalier Henri Mondor d'Aurillac

Aurillac, 15000, France

RECRUITING

Centre de Lutte contre le Cancer - Institut Bergonié

Bordeaux, 33000, France

RECRUITING

Centre de Lutte contre le Cancer - Centre François Baclesse

Caen, 14000, France

RECRUITING

Centre Hospitalier Universitaire Caen Normandie

Caen, 14000, France

RECRUITING

Centre de Lutte contre le Cancer - Jean Perrin

Clermont-Ferrand, 63000, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Hôpitaux civils de Colmar

Colmar, 68024, France

RECRUITING

Centre Régional de Lutte contre le Cancer - Georges Francois Leclerc

Dijon, 21079, France

RECRUITING

Hôpital privé le Bois

Lille, 59000, France

RECRUITING

Centre Hospitalier de Montluçon

Montluçon, 03100, France

NOT YET RECRUITING

Centre Hospitalier de Moulins-Yzeure

Moulins, 03000, France

RECRUITING

Hôpital Saint-Louis APHP

Paris, 75010, France

RECRUITING

Hôpital Beaujon AP-HP

Paris, 92110, France

RECRUITING

Institut Godinot

Reims, France

RECRUITING

Centre Hospitalier Yves Le Foll

Saint-Brieuc, France

RECRUITING

CH Valenciennes

Valenciennes, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

MeSH Terms

Conditions

Neuralgia; Neoplasms

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lise LACLAUTRE

CONTACT

473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Cancer patients and Healthy Volunteers
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 22, 2024
• Study Start: October 28, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-06

Locations

FR (19)