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Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment, A Pilot Study

Phase 1
21 Years
Not Enrolling
Breast Cancer, Cognitive Symptoms, Memory Disorders

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Trial Information

Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment, A Pilot Study

Breast cancer is the most common malignancy in women in the United States, with an estimated
211,240 new cases of invasive breast cancer diagnosed among women, and 1,700 diagnosed in
men, in 2005. While cure rates have improved significantly, chemotherapy for breast cancer
is associated with a number of negative side effects. One of which is a deficit in
cognitive function, a condition commonly referred to as "chemobrain". While the debate
about cognitive decline being a result of chemotherapy is still ongoing, there is clear
evidence of cognitive decline in women with breast cancer post-chemotherapy. Cognitive
decline is often reported to affect memory, attention, executive functioning and information
processing speed.

Studies suggest that incidence of "chemobrain" ranges from 17% - 75% in women who have
undergone chemotherapy.This cognitive impairment affects quality of life by impacting
patients' ability to concentrate, make decisions and to fulfill family, career, and
community responsibilities.

Although there is uncertainty about the mechanisms that can lead to this cognitive decline,
there is a pressing need to identify interventions that will alleviate its symptoms and help
breast cancer survivors recover their cognitive functioning and resume their roles and
activities at the pre-cancer level.

Brain plasticity refers to the brain's capacity for physical and functional change; it is
this capacity that explains how experience induces learning throughout life. On the basis
of a growing body of literature in the fields of psychophysics, neurology, neuropsychology,
and brain plasticity, we hypothesize that the brain processing machinery can be refined,
elaborated, and strengthened through rigorous training and learning. The purpose of this
study is to investigate if such training can improve cognitive functioning.

We hypothesize that continuous active interaction with environments that are demanding to
sensory, cognitive, and motor systems, together with imbedded rewards for successful
performance will help improve memory and cognitive functioning in patients suffering from

Inclusion Criteria:

- Age 21 or older at the time of consent.

- Diagnosis of invasive breast cancer or recurrence warranting treatment with
chemotherapeutic agents in the past 5 years.

- Cognitive decline, as reported by the patient, friends, or family.

- Fluent English speaker.

- Willing and able to commit to the 6-month time requirement of the entire study

- Willing to provide informed consent

- Willing to participate in training of the program.

- Agrees to weekly contact

Exclusion Criteria:

- Severe hearing impairments that would:

- limit the ability to receive instructions and support; and

- hinder performance on the computer training program.

- Self-report of untreated Axis I or II disorders (with the exception of depression,
anxiety disorders, and panic disorders).

- Self-report of current diagnosis or history of major neurological illness including,
but not limited to:

- Alzheimer's disease

- Parkinson's disease

- Multiple sclerosis

- Amyotrophic lateral sclerosis

- History of a stroke, transient ischemic attack (TIA) or traumatic brain injury within
the past year; or lifetime history of stroke, TIA, or traumatic brain injury that has
left residual expressive or receptive language problems.

- Self-report of fibromyalgia or symptoms of tremor severe enough to prevent the use of
a computer mouse or other pointing device.

- Unwillingness to complete the required assessments.

- Patient is not capable of giving informed consent or unable to comprehend and/or
follow instructions.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Examination of the quantitative training program progression data

Principal Investigator

Henry W Mahncke, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Posit Science Corporation


United States: Institutional Review Board

Study ID:

OUT-113-2005; 06140-01



Start Date:

October 2006

Completion Date:

June 2008

Related Keywords:

  • Breast Cancer
  • Cognitive Symptoms
  • Memory Disorders
  • Breast Cancer
  • Cognitive Impairment
  • Chemofog
  • Chemobrain
  • Post-chemotherapy cognitive impairment
  • Breast Neoplasms
  • Memory Disorders
  • Cognition Disorders
  • Neurobehavioral Manifestations



Posit Science Corporation San Francisco, California  94104