Breast CancerNCT00896324
Intellectual Impairment in Women With Breast Cancer
A study testing Cognitive Rehabilitation and Active Neurofeedback Training in people with Breast Cancer, run by Stanford University at 1 site in United States.
Trial summary
RATIONALE: Breast cancer and its treatment may cause changes in a patient's ability to think, learn, and remember. Gathering information about a woman's genes, brain function, and personal history may help doctors learn more about the disease and plan the best treatment. PURPOSE: 1. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cognitive Rehabilitation and Active Neurofeedback Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2009to Jun 2013
- Phase
- Interventional
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 3.1.1 Primary, non-metastatic breast cancer
- 3.1.2 Newly diagnosed patients who have not yet begun treatment.
- 3.1.4 Female participants age 40-65 years of all ethnicities who speak fluent English will be recruited.
- 3.1.5 There are no life expectancy restrictions.
- 3.1.6 Karnofsky Performance Status 70% minimum. ECOG will not be employed.
- 3.1.7 There are no requirements for marrow function. The brain must be free from gross neuropathology and metastases in order to participate.
- 3.1.8 Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 3.2.1 History of cognitive, psychiatric or medical conditions prior or unrelated to cancer diagnosis and/or known to significantly impact assessments (e.g. premature birth, developmental delays, learning disabilities, severe psychiatric conditions, brain injury, stroke). Non-English speaking. Major sensory impairment (e.g. hearing loss, blindness) that would render assessments invalid. MRI contraindications (e.g. metallic implants or devices). Distant metastases. See also section 4.2.1.
- 3.2.2 Participants currently involved in studies specifically aimed at improving cognitive symptoms will be excluded.
- 3.2.3 Participants with significant co-morbid diseases known to significant impact neuropsychological function such as Alzheimer's or Parkinson's will be excluded.
- 3.2.4 There are no known risks for allergic reactions to any of the study procedures.
- 3.2.5 Participants taking certain medications that affect neuropsychological and/or brain function including Haldol, Aricept, Ritalin, etc. will be excluded. Most anti-depressants are acceptable. Some anti-anxiety medications may not be. Each case will be individually reviewed.
- 3.2.6 There are no other agent-specific exclusion criteria.
- 3.2.7 Pregnant individuals will be excluded as this is a contraindication for the 3 Tesla research MRI scanner employed by this study but not because of the treatment programs per se. Nursing individuals can enroll.
- 3.2.8 Patients who are HIV positive will be excluded given the known effects of this condition on cognitive function which would confound the effects of anti-cancer treatments on cognitive outcome.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Assessment and Treatment of Cognitive Deficits in Breast Cancer
RATIONALE: Breast cancer and its treatment may cause changes in a patient's ability to think, learn, and remember. Gathering information about a woman's genes, brain function, and personal history may help doctors learn more about the disease and plan the best treatment.
PURPOSE:
- To determine changes in brain function that occur following breast cancer chemotherapy.
- To gain further understanding of the individual differences in brain function changes and recovery based on demographic, medical and treatment variables.
Read the detailed description
This study aims to determine some of the genetic, neurobiologic and demographic factors that are associated with cognitive outcome following breast cancer (BC). Additionally, it aims to test novel behavioral interventions designed to improve executive function skills following BC treatment.
- Conditions
- Breast Cancer
- Being tested
- Cognitive Rehabilitation, Active Neurofeedback Training, Neurofeedback Training (placebo / Sham)
- Keywords
- Quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RehabilitationBehavioural
The cognitive rehabilitation procedure will involve a curriculum of game-like cognitive exercises designed to facilitate graded practice of EF skills including attention, processing speed, mental flexibility, planning and logic. The exercises will be delivered to participants via a secure, password protected website created specifically for this study by the PI. Subjects will complete a curriculum of cognitive exercises 30 minutes per day, 5 days per week for 6-weeks.
Active Neurofeedback TrainingBehavioural
Neurofeedback training is a type of biofeedback during which the subjects will be trained to improve cognitive function by implementing certain cognitive strategies while receiving feedback of their own brain activity. This is done using an infrared spectroscopy (NIRS) system. NIRS measurements will be performed using an ETG-4000 NIRS system (Hitachi Medical, Tokyo, Japan), at two wavelengths of near-infrared light (695 and 830 nm). Each participant will have 2 or 3 sessions, each lasting approximately 30 minutes.
Neurofeedback Training (placebo / Sham)Behavioural
Neurofeedback training: 2-3, 30 min training sessions. For the sham placebo group, fabricated real-time data will be provided to the subject as feedback information hence enabling the subject to view information identical to experimental subjects but without accurate data pertaining to their own brain activation. The technician will be blinded to the subject's treatment condition assignment.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Rehabilitation (Breast Cancer(BC) with chemotherapy) | Active comparator | Cognitive rehabilitation is a very low-risk method of treatment for cognitive deficits that involves restoring impaired function and/or training the individual to compensate for the area of deficit. Subjects will complete a curriculum of cognitive exercises 30 minutes per day, 5 days per week for 6-weeks. Receives: Behavioral: Cognitive Rehabilitation |
| Active Neurofeedback (BC pre-chemotherapy) | Active comparator | In active Neurofeedback session subjects will be trained to increase brain activation in regions associated with executive function (EF) function deficits (as determined by neuroimaging measures) by viewing their own brain activation in real-time. The "dose" will be 2-3 sessions, each lasting approximately 30 minutes. Receives: Behavioral: Active Neurofeedback Training |
| Neurofeedback placebo (Sham) (BC pre-chemotherapy) | Sham comparator | Neurofeedback training: 2-3, 30 min training sessions. For the sham placebo group, fabricated real-time data will be provided to the subject as feedback information hence enabling the subject to view information identical to experimental subjects but without accurate data pertaining to their own brain activation. The technician will be blinded to the subject's treatment condition assignment. Receives: Behavioral: Neurofeedback Training (placebo / Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the effectiveness of a cognitive rehabilitation program for improving executive function (EF) deficits for preventing or lessening EF impairments in women with Breast Cancer
Evaluation of efficacy of executive function (EF) will be done via Neuropsychological and Neuroimaging (using functional MRI) assessments. Measurements of executive function, memory, processing speed, attention, visual-spatial processing and language will be compared before and after 6 weeks of cognitive rehabilitation program. Neuropsychological assessment and neuroimaging assessment changes will be compared from baseline to post-assessment in the intervention groups. Mixed effects approach and reliable change index (RCI) will be used as a supplementary analysis to determine the change in cognitive testing scores from pre- to post-intervention.Specific neuroimaging data (e.g. prefrontal cortex volumes, hippocampal metabolite levels, whole brain white matter fractional anisotropy) will be correlated with neuropsychological testing scores.
Measured: 6 weeks
Secondary outcomes (2)
Examine the effectiveness of neurofeedback training program for preventing or reducing cognitive deficits in women with Breast Cancer
Neurofeedback training test will be done on women with BC, prior to receiving adjuvant chemotherapy. For the sham placebo group, fabricated real-time data will be provided to the subject as feedback information. Prefrontal and parietal regions of interest will be measured by putting a nylon cap attached to 16 optode emitter/receiver pairs on each subject's head covering the bilateral frontal and parietal regions symmetrically. Measurements will be recorded every 0.1s. The pretask baseline will be determined
Measured: up to 6 months
Evaluate diurnal cortisol levels on executive function outcome in women with Breast cancer
Saliva collection for cortisol analysis will be done with women with BC/chemotherapy, women BC/ no chemotherapy and healthy women. Saliva samples for cortisol analysis will be collected from subjects on 2 consecutive days after the neuropsychological testing and MRI scan have been completed using SARSTEDT Salivettes. Cortisol analysis will be conducted using luminescence immunoassay. The cortisol slope of baseline days will be used as a measure of baseline cortisol level. Cortisol Levels will be correlated with cognitive testing scores.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study start12 Jan 2009
- Primary completionJun 2013
- Study completionJun 2013
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 Stanford UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pre-chemotherapy participants are randomized between active neurofeedback, and a sham (placebo) neurofeedback.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oxana Palesh, Stanford University
- Investigators
- Oxana Palesh, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896324
- Sponsor's protocol ID
- IRB-14623 part 1
- Other IDs
- SU-04062009-2139, BRS0002
- Status last verified
- Aug 2018
- First submitted
- 7 May 2009
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Treatment of Cognitive Deficits in Breast Cancer
- ClinicalTrials.gov ID
- NCT00896324
- Acronym / sponsor ID
- IRB-14623 part 1
- Conditions
- Breast Cancer
- Keywords
- Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 12 Jan 2009 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 May 2009 (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.
RATIONALE: Breast cancer and its treatment may cause changes in a patient's ability to think, learn, and remember. Gathering information about a woman's genes, brain function, and personal history may help doctors learn more about the disease and plan the best treatment.
PURPOSE:
- To determine changes in brain function that occur following breast cancer chemotherapy.
- To gain further understanding of the individual differences in brain function changes and recovery based on demographic, medical and treatment variables.
Detailed description
This study aims to determine some of the genetic, neurobiologic and demographic factors that are associated with cognitive outcome following breast cancer (BC). Additionally, it aims to test novel behavioral interventions designed to improve executive function skills following BC treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Pre-chemotherapy participants are randomized between active neurofeedback, and a sham (placebo) neurofeedback.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Rehabilitation (Breast Cancer(BC) with chemotherapy) | Active comparator | Behavioral: Cognitive RehabilitationCognitive rehabilitation is a very low-risk method of treatment for cognitive deficits that involves restoring impaired function and/or training the individual to compensate for the area of deficit. Subjects will complete a curriculum of cognitive exercises 30 minutes per day, 5 days per week for 6-weeks. |
| Active Neurofeedback (BC pre-chemotherapy) | Active comparator | Behavioral: Active Neurofeedback TrainingIn active Neurofeedback session subjects will be trained to increase brain activation in regions associated with executive function (EF) function deficits (as determined by neuroimaging measures) by viewing their own brain activation in real-time. The "dose" will be 2-3 sessions, each lasting approximately 30 minutes. |
| Neurofeedback placebo (Sham) (BC pre-chemotherapy) | Sham comparator | Behavioral: Neurofeedback Training (placebo / Sham)Neurofeedback training: 2-3, 30 min training sessions. For the sham placebo group, fabricated real-time data will be provided to the subject as feedback information hence enabling the subject to view information identical to experimental subjects but without accurate data pertaining to their own brain activation. The technician will be blinded to the subject's treatment condition assignment. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 3.1.1 Primary, non-metastatic breast cancer
- 3.1.2 Newly diagnosed patients who have not yet begun treatment.
- 3.1.4 Female participants age 40-65 years of all ethnicities who speak fluent English will be recruited.
- 3.1.5 There are no life expectancy restrictions.
- 3.1.6 Karnofsky Performance Status 70% minimum. ECOG will not be employed.
Key exclusion criteria (8 listed)
- 3.2.1 History of cognitive, psychiatric or medical conditions prior or unrelated to cancer diagnosis and/or known to significantly impact assessments (e.g. premature birth, developmental delays, learning disabilities, severe psychiatric conditions, brain injury, stroke). Non-English speaking. Major sensory impairment (e.g. hearing loss, blindness) that would render assessments invalid. MRI contraindications (e.g. metallic implants or devices). Distant metastases. See also section 4.2.1.
- 3.2.2 Participants currently involved in studies specifically aimed at improving cognitive symptoms will be excluded.
- 3.2.3 Participants with significant co-morbid diseases known to significant impact neuropsychological function such as Alzheimer's or Parkinson's will be excluded.
- 3.2.4 There are no known risks for allergic reactions to any of the study procedures.
- 3.2.5 Participants taking certain medications that affect neuropsychological and/or brain function including Haldol, Aricept, Ritalin, etc. will be excluded. Most anti-depressants are acceptable. Some anti-anxiety medications may not be. Each case will be individually reviewed.
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 |
|---|---|---|
| Cognitive RehabilitationThe cognitive rehabilitation procedure will involve a curriculum of game-like cognitive exercises designed to facilitate graded practice of EF skills including attention, processing speed, mental flexibility, planning and logic. The exercises will be delivered to participants via a secure, password protected website created specifically for this study by the PI. Subjects will complete a curriculum of cognitive exercises 30 minutes per day, 5 days per week for 6-weeks. | Behavioural | Cognitive Rehabilitation (Breast Cancer(BC) with chemotherapy) |
| Active Neurofeedback TrainingNeurofeedback training is a type of biofeedback during which the subjects will be trained to improve cognitive function by implementing certain cognitive strategies while receiving feedback of their own brain activity. This is done using an infrared spectroscopy (NIRS) system. NIRS measurements will be performed using an ETG-4000 NIRS system (Hitachi Medical, Tokyo, Japan), at two wavelengths of near-infrared light (695 and 830 nm). Each participant will have 2 or 3 sessions, each lasting approximately 30 minutes. | Behavioural | Active Neurofeedback (BC pre-chemotherapy) |
| Neurofeedback Training (placebo / Sham)Neurofeedback training: 2-3, 30 min training sessions. For the sham placebo group, fabricated real-time data will be provided to the subject as feedback information hence enabling the subject to view information identical to experimental subjects but without accurate data pertaining to their own brain activation. The technician will be blinded to the subject's treatment condition assignment. | Behavioural | Neurofeedback placebo (Sham) (BC pre-chemotherapy) |
Primary outcome
Examine the effectiveness of a cognitive rehabilitation program for improving executive function (EF) deficits for preventing or lessening EF impairments in women with Breast Cancer
Time frame: 6 weeks
Evaluation of efficacy of executive function (EF) will be done via Neuropsychological and Neuroimaging (using functional MRI) assessments. Measurements of executive function, memory, processing speed, attention, visual-spatial processing and language will be compared before and after 6 weeks of cognitive rehabilitation program. Neuropsychological assessment and neuroimaging assessment changes will be compared from baseline to post-assessment in the intervention groups. Mixed effects approach and reliable change index (RCI) will be used as a supplementary analysis to determine the change in cognitive testing scores from pre- to post-intervention.Specific neuroimaging data (e.g. prefrontal cortex volumes, hippocampal metabolite levels, whole brain white matter fractional anisotropy) will be correlated with neuropsychological testing scores.
2 secondary outcomes
Examine the effectiveness of neurofeedback training program for preventing or reducing cognitive deficits in women with Breast Cancer
Time frame: up to 6 months
Evaluate diurnal cortisol levels on executive function outcome in women with Breast cancer
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: No
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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.
Oxana Palesh principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Rehabilitation and Active Neurofeedback Training in people with Breast Cancer, run by Stanford University 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 1 May 2019. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine the effectiveness of a cognitive rehabilitation program for improving executive function (EF) deficits for preventing or lessening EF impairments in women with Breast Cancer (time frame: 6 weeks). 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 1 May 2019.