An observational study in Breast Cancer, sponsored by Nadine ATTAL. Recruiting at 1 site in France. Open to female participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Nadine ATTAL · Observational
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 (±1 week) after completion of chemotherapy, on chronic pain over a one-year period following inclusion. Chronic pain is defined as persistent pain intensity ≥4.
The GCS includes 8 measures derived from cognitive tests assessing long-term memory, inhibition, cognitive flexibility, verbal fluency (categorical and phonemic), nonverbal fluency, working memory, and phasic attention.
The primary endpoint is the comparison of the percentage of patients with chronic pain between patients with and without cognitive impairment at 6 months after chemotherapy completion (T3).
Secondary Objectives:
Assessments will be performed at the following time points:
T1: before chemotherapy, but after surgery T2: after completion of chemotherapy (± 2 weeks) T3: 6 months after completion of chemotherapy (± 1 week)
Benefits: Patients experiencing chronic pain may benefit from pain management at specialized pain centers (CETD - Ambroise Paré Hospital, Institut Curie, Saint-Cloud). Patients may also be referred to a Memory Resource and Research Center (CMRR) for management of cognitive impairment, or to community-based speech therapists or neuropsychologists.
Risks: There are no anticipated risks for breast cancer patients or control participants, as the study only involves neuropsychological testing and questionnaire completion.
Constraints: Participants will be required to attend study visits to complete neuropsychological assessments and questionnaires throughout the longitudinal follow-up period.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 182 is close to the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Nadine ATTAL is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Female patients with non-metastatic, hormone receptor-positive breast cancer who had not received chemotherapy prior to study enrollment, in order to avoid pre-existing cognitive impairment related to the neurotoxic effects of chemotherapy.
Patients will be enrolled in the adjuvant setting following surgery and received a standardized treatment sequence consisting of surgery, anthracycline- and taxane-based chemotherapy, radiotherapy, and endocrine therapy.
Participant recruitment will be conducted by Dr. Marie Péchard (Investigator), Pain Specialist and Consultant Physician at the Comprehensive Cancer Center (Institut Curie, Saint-Cloud, Department of Anesthesiology, Critical Care and Pain Medicine). Participants will be recruited consecutively.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
with or without cogntive deficits
Behavioral: Evaluation of cognitive functions in patients with beast cancer
interventions involving cognitive functions such as executive functions, long term memory, selective, sustained and divided attention, speed processing
Prevalence of chronic pain in patients with and without cognitive disorders.
Comparison of the proportion (%) of patients with chronic pain (defined as pain intensity ≥ 4/10 on a numerical pain rating scale, with 0 : no pain and 10 : maximal pain) in patients with cognitive disorders compared to those without cognitive disorders. The presence of cognitive disorders will be based on the global composite score (8 measures assessing various dimensions of cognition).
Time frame: 6 months ± 1 week after completion of chemotherapy
Prevalence of chronic pain 2 weeks after completion of chemotherapy in patients with and without cognitive disorders
Proportion (%) of patients with chronic pain (defined as pain intensity ≥4/10 on a numerical pain rating scale with 0 = no pain and 10 = maximal pain intensity), 2 weeks after completion of chemotherapy in patients with cognitive disorders compared with those without cognitive disorders.
Time frame: Two weeks after completion of chemotherapy
Affective and sensory dimensions of pain on the short form McGill pain questionnaire
Affective and sensory dimensions of pain based on the short-form McGill Pain Questionnaire (score out of 12 for the affective dimension and 33 for the sensory dimension) in patients with and without cognitive disorders
Time frame: 2 weeks and 6 months after completion of chemotherapy
Prevalence of neuropathic pain in patients with or without cognitive disorders
Proportion (%) of patients with neuropathic pain based on the DN4 questionnaire (10 items). This proportion will be compared in patients with cognitive disorders and those without cognitive disorders
Time frame: 2 weeks and 6 months after chemotherapy
Characteristics of neuropathic pain
Characteristic of neuropathic pain based on the Neuropathic Pain Symptom Inventory (NPSI) in patients with and without cognitive disorders. This questionnaire includes 5 dimensions, each scored on a numerical scale from 0 to 10 : Spontaneous burning pain, deep pain, Paroxysmal pain, Evoked pain and Paresthesia/dysesthesia.
Time frame: 2 weeks and 6 months after completion of chemotherapy
Area of pain
Area of pain (number of pain sites on a body map) in patients with and without cognitive disorders
Time frame: 2 weeks and 6 months after chemotherapy
Correlation between pain intensity and cognitive performance
Correlation between chronic pain intensity (average pain on the Brief Pain Inventory assessed on a 0-10 NRS) and the composite global score (8 cognitive domains)
Time frame: 2 weeks and 6 months after chemotherapy
Prevalence of chronic pain in those with and without working memory complaints.
Proportion (%) of patients with chronic pain (defined as pain ≥ 4/10 on the "average pain" item of the Brief Pain Inventory (BPI)), among patients with working memory complaints compared with those without working memory complaints, based on the Working Memory Questionnaire. Scores will be compared with published age- and education-adjusted normative data.
Time frame: 2 weeks and 6 months after chemotherapy
Prevalence of chronic pain in patients with and without subjective cognitive complaints.
Proportion (%) of patients with chronic pain ( defined as pain ≥ 4/10 on the "average pain" item of the Brief Pain Inventory (BPI)), in patients with and without subjective cognitive complaints based on the Perceived Cognitive Impairment (PCI) subscale (PCI-18 score \<54 or PCI-20 score \<60).
Time frame: 2 weeks and 6 months after chemotherapy
Influence of cognitive impairment on pain coping strategies in patients with and without chronic pain
Influence of cognitive impairment (based on the global composite score) on Pain coping strategies (based on the Coping Strategies Questionnaire (CSQ) scores) in patients with chronic pain and without chronic pain. Chronic pain will be defined as pain ≥ 4/10 on the "average pain" item of the Brief Pain Inventory (BPI).
Time frame: 2 weeks and 6 months after chemotherapy
Influence of Fatigue score in patients with and without chronic pain depending on their cognitive status
Influence of fatigue score, based on the Multidimensional Fatigue Inventory (FMI) in patients with and without pain (defined as a score ≥ 4/10 on the "average pain" item of the Brief Pain Inventory (BPI)), depending on the cognitive status. This will be measured using analysis of covariance.
Time frame: 2 weeks and 6 months after chemotherapy
Influence of Sleep index score in patients with and without chronic pain depending on the cognitive status.
Influence of sleep disorders, based on the Pittsburgh Sleep Quality Index (PSQI), in patients with and without pain (defined as a score ≥4/10 on the "average pain" item of the Brief Pain Inventory (BPI)), depending on the cognitive status.
Time frame: 2 weeks and 6 months after chemotherapy
Influence of Anxiety symptoms in patients with and without chronic pain depending on the cognitive status
Influence of anxiety symptoms, based on the Hospital Anxiety and Depression Rating Scale (HADRS), in patients with and without chronic pain (pain defined as a score ≥ 4/10 on the "average pain" item of the Brief Pain Inventory (BPI)), depending on the cognitive status.
Time frame: 2 weeks and 6 months after chemotherapy
Influence of Depressive symptoms in patients with and without chronic pain depending on the cognitive status
Influence of depressive symptoms, based on the Hospital Anxiety and Depressive Rating scale (HADRS), in patients with and without chronic pain (pain defined as a score ≥ 4/10 on the "average pain" item of the Brief Pain Inventory (BPI)), depending on the cognitive status.
Time frame: 2 weeks and 6 months after chemotherapy
Plan to share: No — Individual participant data (IPD) will not be publicly shared. Aggregated and anonymized results will be published in peer-reviewed journals and presented at scientific conferences. Access to additional data may be considered upon reasonable request to the corresponding investigator, subject to ethical and regulatory approvals.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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