Clinical trial NCT02515487: An Investigation of Chemotherapy Induced Cognitive Impairments in Breast Cancer Survivors
Official title: An Investigation of Chemotherapy Induced Cognitive Impairments in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Post-chemotherapy
cognitive impairment
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-08-04
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main goal of this project is to identify and remediate the cognitive difficulties, including processing speed and attention deficits in individuals who have undergone chemotherapy treatment. Recent research has demonstrated objective cognitive deficits following chemotherapy and that it is not an emotional reaction to the cancer diagnosis as it was once considered. There are a large number of woman diagnosed and treated for breast cancer that experience chemotherapy induced cognitive deficits.

Subjects who participate in the study will be evaluated for cognitive abilities prior to chemotherapy treatment and after completion of chemotherapy. Participants will then have the option to participate in the second phase of the study, which involves the use of a computer-based Brain Fitness Program for 12 weeks. This is followed by another cognitive evaluation.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of breast cancer with adjuvant chemotherapy treatment
2. all subjects will be between the ages of 18 and 70 years old
3. free from significant psychiatric history
4. free of current alcohol or drug abuse.
5. All participants need to understand and read English and have the capacity to consent.

Exclusion Criteria:

1. Individuals with pre-exiting neurological disorder (i.e. brain tumors, dementia, Parkinson's disease, multiple sclerosis, seizure disorder) or diagnosed with metastasis cancer.
2. Individuals younger than 18 years old and older than 70 years old will also be excluded due to developmental changes that occur in those years.
3. Individuals with a current substance use disorder will also be excluded.
4. Individuals who lack the capacity to consent will be excluded from this study.

Primary outcomes:
measure: Change in Wechsler Test of Adult Reading (WTAR)
timeFrame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
measure: Change in Processing Speed (PS)
timeFrame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
measure: Change in Executive Functions
timeFrame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
measure: Change in Working Memory and Attention
timeFrame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
measure: Change in Visual and Verbal Memory
timeFrame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
measure: Change in Depression
timeFrame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
measure: Change in Anxiety
timeFrame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
measure: Change in Frontal Systems Behavior Scale (FRSBE)
timeFrame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
measure: Change in Cognitive Self-Report Questionnaire (CSRQ)
timeFrame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
measure: Change in Functional Assessment of Cancer Therapy-Cognitive Scale (FACT-Cog)
timeFrame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
measure: Change in Functional Assessment of Cancer Therapy - Fatigue scale (FACIT-F)
timeFrame: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Perlmutter Cancer Center
state: New York
Study officials:
affiliation: New York University
name: Gerald Voelbel, PhD
role: PRINCIPAL_INVESTIGATOR
References: