Breast CancerCactusNCT07877376
Impact of Cognitive Impairment on Chronic Pain in Breast Cancer
An observational study of Breast Cancer, run by Nadine ATTAL at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Evaluation of cognitive functions in patients with beast cancer
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 182 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2026to Mar 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Inserm U 987
Boulogne-Billancourt, IDE, 92104
About this study
Official title: To Assess the Impact of Cancer Treatment-Induced Cognitive Impairment on Chronic Pain in Patients With Breast Cancer Over a One-year Period.
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:
Read more
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:
- Compare the percentage of chronic pain in patients with and without cognitive impairment at T2 (±2 weeks after chemotherapy completion), based on persistent pain intensity ≥4/10 on the Brief Pain Inventory (BPI).
- Compare chronic pain characteristics and pain-related disability between patients with and without cognitive impairment at T2 and T3, including etiology, incidence, severity, localization, and disability. Pain characteristics will be assessed using the BPI, McGill Pain Questionnaire, DN4, NPSI, and a body diagram.
- Compare, at T2 and T3, cognitive test scores used to calculate the GCS in patients with chronic pain to determine whether impairment in specific cognitive functions has a greater influence on chronic pain.
- Compare the percentage of chronic pain in patients with cognitive complaints versus those without cognitive complaints at T2 and T3. Cognitive complaints will be assessed using the FACT-Cog and WMQ questionnaires.
- Evaluate the influence of cognitive impairment on pain coping strategies at T2 and T3 using the Coping Strategies Questionnaire (CSQ).
- Evaluate the influence of cognitive impairment on fatigue, anxiety, depressive symptoms, and sleep disturbances in patients with and without chronic pain at T2 and T3. Fatigue will be assessed using the MFI, sleep disturbances using the PSQI, and anxiety/depressive symptoms using the HADS.
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)
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Evaluation of cognitive functions in patients with beast cancer
- Keywords
- Breast cancer, chronic pain, cognitive impairment, chemotherapy
- Medical subject headings
- Breast Neoplasms, Chronic Pain, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of cognitive functions in patients with beast cancerBehavioural
interventions involving cognitive functions such as executive functions, long term memory, selective, sustained and divided attention, speed processing
| Study group | Role | What they receive |
|---|---|---|
| Cognitive statut | with or without cogntive deficits Receives: Behavioral: Evaluation of cognitive functions in patients with beast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months ± 1 week after completion of chemotherapy
Secondary outcomes (13)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks and 6 months after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start9 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Nadine ATTAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nadine ATTAL, Hospital Ambroise Paré Paris
- Investigators
- Nadine Attal, MD, PhD, Study director, French National Institute of Health and Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877376
- Sponsor's protocol ID
- 2024-A01313-44
- Acronym
- Cactus
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Impact of Cancer Treatment-Induced Cognitive Impairment on Chronic Pain in Patients With Breast Cancer Over a One-year Period.
- ClinicalTrials.gov ID
- NCT07877376
- Acronym / sponsor ID
- Cactus / 2024-A01313-44
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, chronic pain, cognitive impairment, chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Nadine ATTALUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Compare the percentage of chronic pain in patients with and without cognitive impairment at T2 (±2 weeks after chemotherapy completion), based on persistent pain intensity ≥4/10 on the Brief Pain Inventory (BPI).
- Compare chronic pain characteristics and pain-related disability between patients with and without cognitive impairment at T2 and T3, including etiology, incidence, severity, localization, and disability. Pain characteristics will be assessed using the BPI, McGill Pain Questionnaire, DN4, NPSI, and a body diagram.
- Compare, at T2 and T3, cognitive test scores used to calculate the GCS in patients with chronic pain to determine whether impairment in specific cognitive functions has a greater influence on chronic pain.
- Compare the percentage of chronic pain in patients with cognitive complaints versus those without cognitive complaints at T2 and T3. Cognitive complaints will be assessed using the FACT-Cog and WMQ questionnaires.
- Evaluate the influence of cognitive impairment on pain coping strategies at T2 and T3 using the Coping Strategies Questionnaire (CSQ).
- Evaluate the influence of cognitive impairment on fatigue, anxiety, depressive symptoms, and sleep disturbances in patients with and without chronic pain at T2 and T3. Fatigue will be assessed using the MFI, sleep disturbances using the PSQI, and anxiety/depressive symptoms using the HADS.
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)
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive statut | – | Behavioral: Evaluation of cognitive functions in patients with beast cancerwith or without cogntive deficits |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of cognitive functions in patients with beast cancerinterventions involving cognitive functions such as executive functions, long term memory, selective, sustained and divided attention, speed processing | Behavioural | Cognitive statut |
Primary outcome
Prevalence of chronic pain in patients with and without cognitive disorders.
Time frame: 6 months ± 1 week after completion of chemotherapy
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).
13 secondary outcomes
Prevalence of chronic pain 2 weeks after completion of chemotherapy in patients with and without cognitive disorders
Time frame: Two weeks after completion of chemotherapy
Affective and sensory dimensions of pain on the short form McGill pain questionnaire
Time frame: 2 weeks and 6 months after completion of chemotherapy
Prevalence of neuropathic pain in patients with or without cognitive disorders
Time frame: 2 weeks and 6 months after chemotherapy
Characteristics of neuropathic pain
Time frame: 2 weeks and 6 months after completion of chemotherapy
Area of pain
Time frame: 2 weeks and 6 months after chemotherapy
Correlation between pain intensity and cognitive performance
Time frame: 2 weeks and 6 months after chemotherapy
Prevalence of chronic pain in those with and without working memory complaints.
Time frame: 2 weeks and 6 months after chemotherapy
Prevalence of chronic pain in patients with and without subjective cognitive complaints.
Time frame: 2 weeks and 6 months after chemotherapy
Influence of cognitive impairment on pain coping strategies in patients with and without chronic pain
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
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.
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
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
Time frame: 2 weeks and 6 months after chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadine Attal, MD, PhD study director
French National Institute of Health and Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Nadine ATTAL at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Didier Bouhassira, MD, PhD (01 49 09 45 56 ext. 33, didier.bouhassira@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of chronic pain in patients with and without cognitive disorders. (time frame: 6 months ± 1 week after completion of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.