Intellectual Impairment in Women With Breast Cancer

NCT00896324 | Completed DMC

• 3 other identifiers: IRB-14623 part 1SU-04062009-2139BRS0002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 1.To determine changes in brain function that occur following breast cancer chemotherapy.
2. 2.To gain further understanding of the individual differences in brain function changes and recovery based on demographic, medical and treatment variables.

Conditions

Breast Cancer

Keywords

Quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (2)

• Examine the effectiveness of neurofeedback training program for preventing or reducing cognitive deficits in women with Breast Cancer

  up to 6 months

• Evaluate diurnal cortisol levels on executive function outcome in women with Breast cancer

  2 days

Study Arms (3)

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.

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.

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.

Behavioral: Neurofeedback Training (placebo / Sham)

Interventions

Cognitive Rehabilitation BEHAVIORAL

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.

Cognitive Rehabilitation (Breast Cancer(BC) with chemotherapy)

Active Neurofeedback Training BEHAVIORAL

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.

Active Neurofeedback (BC pre-chemotherapy)

Neurofeedback Training (placebo / Sham) BEHAVIORAL

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.

Neurofeedback placebo (Sham) (BC pre-chemotherapy)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary, non-metastatic breast cancer
• Newly diagnosed patients who have not yet begun treatment.
• Female participants age 40-65 years of all ethnicities who speak fluent English will be recruited.
• There are no life expectancy restrictions.
• Karnofsky Performance Status 70% minimum. ECOG will not be employed.
• There are no requirements for marrow function. The brain must be free from gross neuropathology and metastases in order to participate.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• 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.
• Participants currently involved in studies specifically aimed at improving cognitive symptoms will be excluded.
• Participants with significant co-morbid diseases known to significant impact neuropsychological function such as Alzheimer's or Parkinson's will be excluded.
• There are no known risks for allergic reactions to any of the study procedures.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cognitive Training; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Oxana Palesh

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry and Behavioral Sciences

Model Details: Pre-chemotherapy participants are randomized between active neurofeedback, and a sham (placebo) neurofeedback.

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 11, 2009
• Study Start: January 12, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 1, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)