Breast CancerNCT02896504
Chemotherapy Effect on Brain Structure, Neurophysiology and Psychomotor Behavior in Breast Cancer Patients
An observational study of Breast Cancer, run by Kessler Foundation at 1 site in United States.
Trial summary
Some cancer patients report experiencing mild problems with thinking during or following chemotherapy. Symptoms include problems concentrating, slow thinking, some gaps in memory and difficulty performing complex or multi-tasks. These symptoms often soon disappear after treatment. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exposure: Adjuvant chemotherapy treatment and Exposure: Adjuvant hormonal therapy treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Newly diagnosed breast cancer patients
Who may be able to join
- For all participants
- Female aged 20-70
- Right handed as determined by the Edinburgh Inventory [40]
- Proficient in English
- For Cancer patients
- Had breast cancer surgery
Show all 12Show fewer
- Stage I, II, IIIa
- Non metastatic cancer
- Chemotherapy Patients: Scheduled to receive or receiving breast cancer chemotherapy with Anthracycline and/or Taxane
- Hormonal Therapy Patients: Scheduled to receive or receiving hormonal therapy with Aromatase inhibitor
- For patients recruited before adjuvant therapy: Adjuvant therapy starts at least 2 weeks after surgery
- For patients recruited after adjuvant therapy started: Before completing/within 1 month post chemotherapy Within 4 months after starting hormonal therapy
Who cannot join
- Symptoms for mild or severe depression as determined by a Patient Health Questionnaire (PHQ-8) score >14
- Significant impairment in ability to understand and analyze information as determined by a Folstein Mini-Mental State Exam score <21.
- Prior history of cancer (except breast cancer for breast cancer patients), trauma, neurological, psychiatric, physical or psychological diseases or other conditions that may influence nervous system structure and function
- Current medication believed to affect cognitive/psychomotor function (i.e., opioid analgesics, anxiolytics or antidepressants)
- History of alcohol, smoking and drug abuse
- Transcranial Magnetic Stimulation or MRI contraindication
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Didier Allexandre, PhD, 973-324-3525, dallexandre@kesslerfoundation.org
Guang Yue, PhD
About this study
Some cancer patients report experiencing mild problems with thinking during or following chemotherapy. Symptoms include problems concentrating, slow thinking, some gaps in memory and difficulty performing complex or multi-tasks. These symptoms often soon disappear after treatment. However for some patients, they may persist for years and this can have a significant effect on their quality of life. The reasons for these symptoms are not well understood.
This study proposes to examine the effects of chemotherapy on the brain and how the changes in the brain affect one's ability to move one's arms and fingers. By better understanding the negative consequences of chemotherapy on the brain and nervous system, the hope is to help pharmaceutical companies develop safer cancer treatment drugs.
Read the detailed description
Adjuvant chemotherapy (CTh) is an established postoperative treatment often prescribed to cancer patients to reduce risk of relapse. However, a great proportion of patients report experiencing cognitive, psychomotor, and other functional impairments associated with CTh. Some symptoms may persist for years after treatment and can have dramatic consequences on cancer survivors' quality of life. Despite numerous studies reporting various symptoms during/after CTh treatment, mechanisms underlying these symptoms are not well understood. Recent animal and human brain imaging studies suggest that CTh may have direct neurotoxic effects on the brain, in particular on brain white matter (WM). However, to date, no longitudinal studies have been done to examine the effects of CTh on cortical/subcortical WM integrity in human patients. Furthermore, no effort has yet been made to correlate a given WM structure with its corresponding neurophysiological function (NPF) and behavior. This study proposes longitudinal experiments in women diagnosed with breast cancer to examine the effects of CTh on the corpus callosum (CC) and corticospinal tract (CST) (Aim 1), on NPF that directly depends on the quality of CC/CST structure, and on psychomotor behavior critically relying on CC/CST function (conductivity) (Aim 2). The relationship between CC/CST structural integrity and their corresponding NPF and psychomotor behavior will also be examined (Aim 3). The general underlying hypotheses of the study are that (1) CTh has a direct neurotoxic effect on the CC and CST, resulting in microstructural degeneration and (2) structural damage to the CC and CST impairs relevant neurophysiological function and behavior. This research is expected to yield significant information regarding neural structural and physiological causes of CTh-related side effects; known this information would help more effectively manage the symptoms. By demonstrating direct evidence of detrimental consequences of CTh on the central nervous system, it is hoped that the evidence would encourage pharmaceutical companies to develop safer cancer treatment drugs.
- Conditions
- Breast Cancer
- Being tested
- Exposure: Adjuvant chemotherapy treatment, Exposure: Adjuvant hormonal therapy treatment
- Keywords
- Chemobrain, Chemotherapy, Hormonal Therapy, Neuroimaging
- Medical subject headings
- Breast Neoplasms, Chemotherapy-Related Cognitive Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure: Adjuvant chemotherapy treatmentDrug
Exposure: Adjuvant hormonal therapy treatmentDrug
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Breast Cancer patients undergoing conventional postsurgical adjuvant chemotherapy treatment Receives: Drug: Exposure: Adjuvant chemotherapy treatment | |
| Hormonal Therapy | Breast Cancer patients undergoing conventional postsurgical adjuvant hormonal therapy treatment (with no Chemotherapy) Receives: Drug: Exposure: Adjuvant hormonal therapy treatment | |
| Healthy Control | Healthy age, height and body-mass matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Structural Integrity of the Corpus Collusum as measure by MRI-DTI
Measured: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control)
Change in Structural Integrity of the cortico-spinal tract as measure by MRI-DTI
Measured: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control)
Change in out-of-phase bimanual finger tapping task performance
Measured: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control)
Change in interhemispheric EEG coherence between the left and right motor brain areas
Measured: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control)
Change in corticomuscular conduction time using Transcranial Magnetic Stimulation
Measured: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control)
Change in response time to a simple reaction time
Measured: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startSep 2013
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (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.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guang Yue, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896504
- Sponsor's protocol ID
- R-739-12
- Status last verified
- Jan 2018
- First submitted
- 6 Sep 2016
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Effect on Brain Structure, Neurophysiology and Psychomotor Behavior in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02896504
- Acronym / sponsor ID
- R-739-12
- Conditions
- Breast Cancer
- Keywords
- Chemobrain, Chemotherapy, Hormonal Therapy, Neuroimaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 12 Sep 2016 (estimated)
- 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.
Some cancer patients report experiencing mild problems with thinking during or following chemotherapy. Symptoms include problems concentrating, slow thinking, some gaps in memory and difficulty performing complex or multi-tasks. These symptoms often soon disappear after treatment. However for some patients, they may persist for years and this can have a significant effect on their quality of life. The reasons for these symptoms are not well understood.
This study proposes to examine the effects of chemotherapy on the brain and how the changes in the brain affect one's ability to move one's arms and fingers. By better understanding the negative consequences of chemotherapy on the brain and nervous system, the hope is to help pharmaceutical companies develop safer cancer treatment drugs.
Detailed description
Adjuvant chemotherapy (CTh) is an established postoperative treatment often prescribed to cancer patients to reduce risk of relapse. However, a great proportion of patients report experiencing cognitive, psychomotor, and other functional impairments associated with CTh. Some symptoms may persist for years after treatment and can have dramatic consequences on cancer survivors' quality of life. Despite numerous studies reporting various symptoms during/after CTh treatment, mechanisms underlying these symptoms are not well understood. Recent animal and human brain imaging studies suggest that CTh may have direct neurotoxic effects on the brain, in particular on brain white matter (WM). However, to date, no longitudinal studies have been done to examine the effects of CTh on cortical/subcortical WM integrity in human patients. Furthermore, no effort has yet been made to correlate a given WM structure with its corresponding neurophysiological function (NPF) and behavior. This study proposes longitudinal experiments in women diagnosed with breast cancer to examine the effects of CTh on the corpus callosum (CC) and corticospinal tract (CST) (Aim 1), on NPF that directly depends on the quality of CC/CST structure, and on psychomotor behavior critically relying on CC/CST function (conductivity) (Aim 2). The relationship between CC/CST structural integrity and their corresponding NPF and psychomotor behavior will also be examined (Aim 3). The general underlying hypotheses of the study are that (1) CTh has a direct neurotoxic effect on the CC and CST, resulting in microstructural degeneration and (2) structural damage to the CC and CST impairs relevant neurophysiological function and behavior. This research is expected to yield significant information regarding neural structural and physiological causes of CTh-related side effects; known this information would help more effectively manage the symptoms. By demonstrating direct evidence of detrimental consequences of CTh on the central nervous system, it is hoped that the evidence would encourage pharmaceutical companies to develop safer cancer treatment drugs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | – | Drug: Exposure: Adjuvant chemotherapy treatmentBreast Cancer patients undergoing conventional postsurgical adjuvant chemotherapy treatment |
| Hormonal Therapy | – | Drug: Exposure: Adjuvant hormonal therapy treatmentBreast Cancer patients undergoing conventional postsurgical adjuvant hormonal therapy treatment (with no Chemotherapy) |
| Healthy Control | – | –Healthy age, height and body-mass matched healthy controls |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed breast cancer patients
Key inclusion criteria (12 listed)
- For all participants
- For Cancer patients
Key exclusion criteria (6 listed)
- Symptoms for mild or severe depression as determined by a Patient Health Questionnaire (PHQ-8) score >14
- Significant impairment in ability to understand and analyze information as determined by a Folstein Mini-Mental State Exam score <21.
- Prior history of cancer (except breast cancer for breast cancer patients), trauma, neurological, psychiatric, physical or psychological diseases or other conditions that may influence nervous system structure and function
- Current medication believed to affect cognitive/psychomotor function (i.e., opioid analgesics, anxiolytics or antidepressants)
- History of alcohol, smoking and drug abuse
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 |
|---|---|---|
| Exposure: Adjuvant chemotherapy treatment | Drug | Chemotherapy |
| Exposure: Adjuvant hormonal therapy treatment | Drug | Hormonal Therapy |
Primary outcome
Change in Structural Integrity of the Corpus Collusum as measure by MRI-DTI
Time frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control)
Change in Structural Integrity of the cortico-spinal tract as measure by MRI-DTI
Time frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control)
Change in out-of-phase bimanual finger tapping task performance
Time frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control)
Change in interhemispheric EEG coherence between the left and right motor brain areas
Time frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control)
Change in corticomuscular conduction time using Transcranial Magnetic Stimulation
Time frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control)
Change in response time to a simple reaction time
Time frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Guang Yue, PhD principal investigator
Kessler Foundation
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 Kessler Foundation at 1 site in United States.
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 12 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Jan 2018. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Didier Allexandre, PhD (973324, dallexandre@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Structural Integrity of the Corpus Collusum as measure by MRI-DTI (time frame: Pre to Post chemotherapy change (or at 6 months for hormonal therapy/control)). The study lists 6 primary outcomes in all. 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 23 Jan 2018; AzTrials last refreshed its copy on 6 Nov 2026.