Breast CancerNCT05305092
Assessment of Brain Cognitive Impairment in Breast Cancer
An observational study of Breast Cancer and Chemo-brain, run by Tang-Du Hospital at 1 site in China.
Trial summary
To explore the cognitive impairment caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients and to find biomarkers with early predictive effect on this cognitive impairment by using multimodal integrated PET/MRI technology combined with psychobehavioral technology. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Chemo-brain, Endocrine Therapy
- What is being tested?
- PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2022to 30 May 2027
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Premenopausal patients with stage I-II breast cancer.
Who may be able to join
- Patients with primary stage I-II breast cancer.
- Premenopausal women (menopausal status determined by National Comprehensive Cancer Network Breast Cancer Guidelines criteria).
- No treatment other than surgery has been started (if neoadjuvant chemotherapy is required before surgery, enroll before chemotherapy starts).
- Eastern Cooperative Oncology Group score of 0-1 points.
- Can understand and complete various scales.
- Right handedness.
- Female subjects of childbearing potential must be willing to use a medically-approved high-efficiency contraceptive method (eg, intra-uterine device, birth control pill, or condom) for the duration of the study.
- Sign the informed consent and voluntarily participate in this clinical observation.
Who cannot join
- Central nervous system (CNS) disease, history of malignancy, chronic loss of consciousness, head trauma, and any disease affecting cognitive function.
- Current or former epilepsy, dementia, or learning disabilities.
- Past psychiatric history.
- Past history of malignancy.
- MRI related contraindications: pacemakers, defibrillators, hearing aids, insulin pumps, drug dose control devices and other metal implants; patients with severe hyperthermia; patients with claustrophobia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi, 710038
Menghui Yuan, PHD, 0086-13519196610, yuanmenghui@163.com
Lijun Bai, PHD, 0086-15129034948, bailijun@xjtu.edu.cn
About this study
Official title: Integrated PET/MRI Study of Cognitive Impairment in Premenopausal Breast Cancer Patients After Chemotherapy or Endocrine Therapy
To explore the cognitive impairment caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients and to find biomarkers with early predictive effect on this cognitive impairment by using multimodal integrated PET/MRI technology combined with psychobehavioral technology.
Read the detailed description
Breast cancer is the most common type of cancer in women worldwide, and cancer-related cognitive impairment (CRCI) has become one of the most concerning clinical problems in breast cancer treatment. This project intends to use the combination of advanced PET/MRI technology and psycho-behavioral methods to observe the cognitive impairment and the changes in brain structure, function and glucose metabolism caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients, then looking for possible predictors, through early identification of patients at risk of cognitive decline after chemotherapy or endocrine therapy, to provide a scientific basis for the rational selection of breast cancer treatment plans in the future.
- Conditions
- Breast Cancer, Chemo-brain, Endocrine Therapy
- Being tested
- PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample
- Keywords
- CRCI, psycho-behavioral technology, Integrated PET/MRI technology, Biomarkers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sampleDevice
Neuroimaging data were collected by integrated PET/MRI machine, and collected the psychobehavioral data, the serum and stool samples of participants.
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Premenopausal breast cancer patients receiving chemotherapy (including preoperative neoadjuvant chemotherapy) and endocrine therapy after surgery Receives: Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample | |
| Endocrine therapy | Premenopausal breast cancer patients receiving endocrine therapy alone after surgery Receives: Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample | |
| Healthy control | Healthy non-cancer controls Receives: Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gray matter volume of whole brain
Gray matter volume will be measured with magnetic resonance imaging (high resolution T1-weighted image)
Measured: Baseline, 6,18,30 months later
Change of white matter integrity of whole brain.
Fractional anisotropy, axial diffusivity and radial diffusivity will be measured with magnetic resonance imaging (diffusion tensor imaging)
Measured: Baseline, 6,18,30 months later
Change of metabolism of glucose in the brain
Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography
Measured: Baseline, 6,18,30 months later
Change of functional connectivity of whole brain
Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence
Measured: Baseline, 6,18,30 months later
Change of verbal learning and memory
Verbal learning and memory scores will be assessed with Hopkins Verbal Learning Test-Revised.The minimum value is 0, and the maximum value is 12. The higher scores mean a better outcome.
Measured: Baseline, 6,18,30 months later
Change of information processing speed
Information processing speed scores will be assessed with Wechsler Adult Intelligence Scale(WAIS-III) Digit Symbol Coding score.The minimum value is 0, and the maximum value is 90. The higher scores mean a better outcome.
Measured: Baseline, 6,18,30 months later
Change of executive function
Executive function scores will be assessed with Stroop color-word test.The minimum value is 0, and the maximum value is 50. The higher scores mean a better outcome.
Measured: Baseline, 6,18,30 months later
Change of attention, verbal short term and working memory
Attention, verbal short term and working memory scores will be assessed with Digit span.The minimum value is 0, and the maximum value is 12. The higher scores mean a better outcome.
Measured: Baseline, 6,18,30 months later
Change of life quality.
Quality of life scores will be assessed with Quality-of-Life Questionnaire C30. The minimum value is 30, and the maximum value is 126. The higher scores mean a worse outcome.
Measured: Baseline, 6,18,30 months later
Change of anxiety
Anxiety scores will be assessed with Self-Rating Anxiety Scale.The minimum value is 20, and the maximum value is 80. The higher scores mean a worse outcome.
Measured: Baseline, 6,18,30 months later
Change of depression
Depression scores will be assessed with Self-rating depression scale.The minimum value is 20, and the maximum value is 80. The higher scores mean a worse outcome.
Measured: Baseline, 6,18,30 months later
Change of fatigue
Fatigue scores will be assessed with Fatigue Severity Scale. The minimum value is 9, and the maximum value is 63. The higher scores mean a worse outcome.
Measured: Baseline, 6,18,30 months later
Change of sleep
Sleep scores will be assessed with Pittsburgh sleep quality index.The minimum value is 9, and the maximum value is 36. The higher scores mean a worse outcome.
Measured: Baseline, 6,18,30 months later
Secondary outcomes (1)
Change of the concentration of serum biomarkers.
The concentration of GFAP with pg/mL, S-100B with pg/mL，IL-6 with pg/mL, IL-8 with pg/mL, IL-10 with pg/mL, IL-1β with pg/mL, TNF-α with pg/mL, UCH-L1 with pg/mL, NSE with pg/mL, T-Tau with pg/mL, P-Tau with pg/mL, NFL with pg/mL, BDNF with pg/mL, and VEGF with pg/mL
Measured: Baseline, 6,18,30 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start31 May 2022
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (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 Tang-Du HospitalThe 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an Jiaotong University
- Responsible party
- Sponsor
- Investigators
- Menghui Yuan, phd, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305092
- Sponsor's protocol ID
- 82071993
- Status last verified
- Jul 2022
- First submitted
- 6 Mar 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated PET/MRI Study of Cognitive Impairment in Premenopausal Breast Cancer Patients After Chemotherapy or Endocrine Therapy
- ClinicalTrials.gov ID
- NCT05305092
- Acronym / sponsor ID
- 82071993
- Conditions
- Breast Cancer, Chemo-brain, Endocrine Therapy
- Keywords
- CRCI, psycho-behavioral technology, Integrated PET/MRI technology, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- Xi'an Jiaotong University
- Study start
- 31 May 2022 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 31 Mar 2022 (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.
To explore the cognitive impairment caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients and to find biomarkers with early predictive effect on this cognitive impairment by using multimodal integrated PET/MRI technology combined with psychobehavioral technology.
Detailed description
Breast cancer is the most common type of cancer in women worldwide, and cancer-related cognitive impairment (CRCI) has become one of the most concerning clinical problems in breast cancer treatment. This project intends to use the combination of advanced PET/MRI technology and psycho-behavioral methods to observe the cognitive impairment and the changes in brain structure, function and glucose metabolism caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients, then looking for possible predictors, through early identification of patients at risk of cognitive decline after chemotherapy or endocrine therapy, to provide a scientific basis for the rational selection of breast cancer treatment plans in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | – | Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool samplePremenopausal breast cancer patients receiving chemotherapy (including preoperative neoadjuvant chemotherapy) and endocrine therapy after surgery |
| Endocrine therapy | – | Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool samplePremenopausal breast cancer patients receiving endocrine therapy alone after surgery |
| Healthy control | – | Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sampleHealthy non-cancer controls |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Premenopausal patients with stage I-II breast cancer.
Key inclusion criteria (8 listed)
- Patients with primary stage I-II breast cancer.
- Premenopausal women (menopausal status determined by National Comprehensive Cancer Network Breast Cancer Guidelines criteria).
- No treatment other than surgery has been started (if neoadjuvant chemotherapy is required before surgery, enroll before chemotherapy starts).
- Eastern Cooperative Oncology Group score of 0-1 points.
- Can understand and complete various scales.
Key exclusion criteria (5 listed)
- Central nervous system (CNS) disease, history of malignancy, chronic loss of consciousness, head trauma, and any disease affecting cognitive function.
- Current or former epilepsy, dementia, or learning disabilities.
- Past psychiatric history.
- Past history of malignancy.
- MRI related contraindications: pacemakers, defibrillators, hearing aids, insulin pumps, drug dose control devices and other metal implants; patients with severe hyperthermia; patients with claustrophobia.
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 |
|---|---|---|
| PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sampleNeuroimaging data were collected by integrated PET/MRI machine, and collected the psychobehavioral data, the serum and stool samples of participants. | Device | Endocrine therapy, Healthy control, chemotherapy |
Primary outcome
Change of gray matter volume of whole brain
Time frame: Baseline, 6,18,30 months later
Gray matter volume will be measured with magnetic resonance imaging (high resolution T1-weighted image)
Change of white matter integrity of whole brain.
Time frame: Baseline, 6,18,30 months later
Fractional anisotropy, axial diffusivity and radial diffusivity will be measured with magnetic resonance imaging (diffusion tensor imaging)
Change of metabolism of glucose in the brain
Time frame: Baseline, 6,18,30 months later
Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography
Change of functional connectivity of whole brain
Time frame: Baseline, 6,18,30 months later
Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence
Change of verbal learning and memory
Time frame: Baseline, 6,18,30 months later
Verbal learning and memory scores will be assessed with Hopkins Verbal Learning Test-Revised.The minimum value is 0, and the maximum value is 12. The higher scores mean a better outcome.
Change of information processing speed
Time frame: Baseline, 6,18,30 months later
Information processing speed scores will be assessed with Wechsler Adult Intelligence Scale(WAIS-III) Digit Symbol Coding score.The minimum value is 0, and the maximum value is 90. The higher scores mean a better outcome.
Change of executive function
Time frame: Baseline, 6,18,30 months later
Executive function scores will be assessed with Stroop color-word test.The minimum value is 0, and the maximum value is 50. The higher scores mean a better outcome.
Change of attention, verbal short term and working memory
Time frame: Baseline, 6,18,30 months later
Attention, verbal short term and working memory scores will be assessed with Digit span.The minimum value is 0, and the maximum value is 12. The higher scores mean a better outcome.
Change of life quality.
Time frame: Baseline, 6,18,30 months later
Quality of life scores will be assessed with Quality-of-Life Questionnaire C30. The minimum value is 30, and the maximum value is 126. The higher scores mean a worse outcome.
Change of anxiety
Time frame: Baseline, 6,18,30 months later
Anxiety scores will be assessed with Self-Rating Anxiety Scale.The minimum value is 20, and the maximum value is 80. The higher scores mean a worse outcome.
Change of depression
Time frame: Baseline, 6,18,30 months later
Depression scores will be assessed with Self-rating depression scale.The minimum value is 20, and the maximum value is 80. The higher scores mean a worse outcome.
Change of fatigue
Time frame: Baseline, 6,18,30 months later
Fatigue scores will be assessed with Fatigue Severity Scale. The minimum value is 9, and the maximum value is 63. The higher scores mean a worse outcome.
Change of sleep
Time frame: Baseline, 6,18,30 months later
Sleep scores will be assessed with Pittsburgh sleep quality index.The minimum value is 9, and the maximum value is 36. The higher scores mean a worse outcome.
1 secondary outcome
Change of the concentration of serum biomarkers.
Time frame: Baseline, 6,18,30 months later
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 13 Jul 2022.
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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.
Menghui Yuan, phd principal investigator
Tang-Du Hospital
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 and Chemo-brain, run by Tang-Du Hospital at 1 site in China.
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 8 inclusion and 5 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 13 Jul 2022. 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 China. 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 Menghui Yuan, phd (0086-13519196610, yuanmenghui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of gray matter volume of whole brain (time frame: Baseline, 6,18,30 months later). The study lists 13 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 13 Jul 2022.