Clinical trial NCT03696056: Improving Brain Function After Breast Cancer Study
Official title: Improving Cognition in Breast Cancer Survivors Using Meditation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Survivors
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will explore the feasibility and potential effects of a simple, home-based daily meditation intervention on breast cancer survivors' cognitive and psychological functioning as well as inflammatory regulation.

Detailed description: This study will compare two home based 8-week interventions (Kirtan Kriya meditation vs.

relaxing instrumental music listening) in 40 breast cancer survivors ages 21-75 who completed chemotherapy 3 months to 5 years prior.

Eligibility criteria: Inclusion Criteria:

* Individuals with a history of non-inflammatory breast cancer (stages I-IV):
* Received chemotherapy as part of their treatment
* Completed chemotherapy treatment 3 months to 10 years prior to study enrollment
* Individuals who have report cognitive deficits

Exclusion Criteria:

* Breast cancer survivors with a history of metastases to the brain
* A physician diagnosis of: dementia, a learning disability, unmanaged major depression, psychosis, schizophrenia, bipolar, traumatic brain injury, cancer of the central nervous system, diabetes, arthritis
* Taking oral steroids within 30 days of enrolling
* A regular meditation practice (greater than 1 time per week)
* Currently taking immune modifying medications

Primary outcomes:
measure: Verbal learning and memory performance-Hopkins Verbal Learning Test Immediate and Delayed Recall
timeFrame: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
measure: Verbal Fluency Performance-Controlled Oral Word Association Test
timeFrame: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
measure: Executive Functioning Performance- Trail Making Test Parts A & B
timeFrame: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Secondary outcomes:
measure: Granulocyte-macrophage colony-stimulating factor concentration
timeFrame: Baseline, and Time 2 (8 weeks after baseline).
measure: Interferon gamma concentration
timeFrame: Baseline, and Time 2 (8 weeks after baseline).
measure: Interleukin-1 β concentration
timeFrame: Baseline, and Time 2 (8 weeks after baseline).
measure: Interleukin-2 concentration
timeFrame: Baseline, and Time 2 (8 weeks after baseline).
measure: Interleukin-4 concentration
timeFrame: Baseline, and Time 2 (8 weeks after baseline).
measure: Interleukin-5 concentration
timeFrame: Baseline, and Time 2 (8 weeks after baseline).
measure: Interleukin-6 concentration
timeFrame: Baseline, and Time 2 (8 weeks after baseline).
measure: Interleukin-7 concentration
timeFrame: Baseline, and Time 2 (8 weeks after baseline).
measure: Interleukin-8 concentration
timeFrame: Baseline, and Time 2 (8 weeks after baseline).
measure: Interleukin-10 concentration
timeFrame: Baseline, and Time 2 (8 weeks after baseline).
measure: Interleukin-12 concentration
timeFrame: Baseline, and Time 2 (8 weeks after baseline).
measure: Interleukin-13 concentration
timeFrame: Baseline, and Time 2 (8 weeks after baseline).
measure: Tumor necrosis factor alpha concentration
timeFrame: Baseline, and Time 2 (8 weeks after baseline).
measure: Self-reported cognitive function
timeFrame: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
measure: Anxiety Symptoms
timeFrame: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
measure: Feelings of depression
timeFrame: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
measure: Perceived Fatigue
timeFrame: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
measure: Perceived stress
timeFrame: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References:
citation: Henneghan AM, Becker H, Harrison ML, Inselmann K, Fico B, Schafer H, King E, Patt D, Kesler S. A randomized control trial of meditation compared to music listening to improve cognitive function for breast cancer survivors: Feasibility and acceptability. Complement Ther Clin Pract. 2020 Nov;41:101228. doi: 10.1016/j.ctcp.2020.101228. Epub 2020 Sep 11.