Trial Title:
Vulnerability and Risk of Neuropathic Pain in Cancer
NCT ID:
NCT06511674
Condition:
Neuropathic Pain
Cancer
Predictive
Conditions: Official terms:
Neuralgia
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Participant)
Masking description:
Cancer patients and Healthy Volunteers
Intervention:
Intervention type:
Other
Intervention name:
Cognitive-emotional and pain assessments
Description:
Data collection on cognitive-emotional and pain parameters using questionnaires.
Arm group label:
Cancer patients
Arm group label:
Healthy volunteers controls
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.
Criteria for 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 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, and 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
CHU de Clermont-Ferrand
Address:
City:
Clermont-Ferrand
Zip:
63000
Country:
France
Investigator:
Last name:
Gisèle Pickering
Email:
Principal Investigator
Facility:
Name:
Nstitut Godinot
Address:
City:
Reims
Country:
France
Facility:
Name:
Centre Hospitalier Yves Le Foll
Address:
City:
Saint Brieuc
Country:
France
Investigator:
Last name:
Homauon ALIPOUR
Email:
Principal Investigator
Facility:
Name:
CH Valenciennes
Address:
City:
Valenciennes
Country:
France
Start date:
September 2, 2024
Completion date:
June 30, 2028
Lead sponsor:
Agency:
University Hospital, Clermont-Ferrand
Agency class:
Other
Source:
University Hospital, Clermont-Ferrand
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06511674
