Impact of cognitive impairment after chemotherapy on chronic pain in breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows women aged 35–65 with non-metastatic, hormone receptor-positive breast cancer who receive standard adjuvant therapy. About six months after completing chemotherapy, cognitive function will be measured with a Global Composite Score based on eight cognitive tests. The researchers will then track chronic pain over the following year, defined as pain with intensity of at least 4. The aim is to see if post-chemotherapy cognitive impairment is linked to higher levels or persistence of chronic pain, using neuropsychological testing and questionnaires collected during follow-up visits. Participants may be connected with pain management resources or cognitive impairment support as appropriate.

Why it matters

Who can join: the full rules

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 ≥75 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

Where it's running

• Inserm U 987
  Boulogne-Billancourt, Ide, France Recruiting

Study contacts

• Study coordinator: Didier Bouhassira, MD, PhD
• Email: didier.bouhassira@inserm.fr
• Phone: 01 49 09 45 56

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.