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โ† Trials
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Impact of Cognitive Impairment on Chronic Pain in Breast Cancer

Recruitingn/aAges 35 Years - 65 YearsFemaleNadine ATTAL
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In plain words

What the trial is, and whether it could suit you

Breast cancer treatments are associated with frequent and sometimes severe adverse effects that may significantly impair quality of life and lead to functional disability. Chronic pain and cognitive impairment are common treatment-related complications. However, no study has yet investigated the influence of cancer treatment-related cognitive impairment on chronic pain in this population. Primary Objective: To evaluate the influence of cognitive impairment, defined as a significant alteration in the Global Composite Score (GCS), measured 6 months (ยฑ1 week) after completion of chemotherapy, on chronic pain over a one-year period following inclusion. Chronic pain is defined as persistent pain intensity โ‰ฅ4. The GCS includes 8 measures derived from cognitive tests assessing long-term memory, inhibition, cognitive flexibility, verbal fluency (categorical and phonemic), nonverbal fluency, w

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: * Female patients aged 35 to 65 years * Signed informed consent * Affiliated with the French social security system or entitled beneficiary * Able to read and understand French * Willing to participate and able to comply with study procedures * Diagnosed with non-metastatic, hormone receptor-positive breast cancer * No prior chemotherapy exposure * Adjuvant treatment setting after surgery) * Receiving the same treatment sequence: surgery, chemotherapy (anthracycline- and taxane-based regimens), radiotherapy, and hormone therapy. Exclusion criteria: * Central nervous system disorders * MMSE score \<26 assessed by the psychologist at the beginning of the inclusion visit (post-inclusion exclusion criterion if MMSE \<26) * Use of tricyclic antidepressants at doses โ‰ฅ75 mg/day; benzodiazepines or antipsychotics * Morbid obesity * Psychiatric disorders (psychosis, major depressive episode, according to DSM-5 diagnostic criteria as assessed by the MINI, or history of suicide attempt) * Alcohol, drug, or psychoactive substance abuse (DSM-5 definition) within the past six months * Persistent or intermittent chronic pain conditions (e.g., irritable bowel syndrome) prior to inclusion * Cognitive or psychological disorders incompatible with protocol adherence and/or comprehension * Ongoing legal dispute or compensation-seeking process * Protected persons as defined in Articles L.1121-5 to L.1121-8 of the French Public Health Code: pregnant or breastfeeding women, prisoners or individuals under judicial or administrative detention, individuals receiving psychiatric care, minors, or adults under legal protection or unable to provide informed consent
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What it tests

  • Evaluation of cognitive functions in patients with beast cancer
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Where

1 site
Inserm U 987
Boulogne-Billancourt, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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