Breast Cancer
Conditions
Keywords
Breast Cancer, Cancer-related cognitive impairment, Non-invasive brain stimulation, Exercise
Brief summary
The purpose of this study is to assess the feasibility of a 4-week intervention combining exercise and transcranial alternating current stimulation (Ex+tACS) in breast cancer survivors who report experiencing cancer-related cognitive impairment. Feasibility will be assessed by measuring participant retention, adherence, satisfaction with the intervention, and safety. The researchers will also examine pre-to-post intervention changes in attention, executive function, working memory, perceived cognitive function, and physical function before, after, and four weeks post intervention completion in the Ex+tACS group compared to a control group who will receive exercise and a placebo tACS condition (CON).
Detailed description
Breast cancer is one of the most common forms of cancer among women in the United States. Although advances in cancer treatments have led to improved survival rates, breast cancer survivors must contend with the negative side effects from the cancer and its treatments. One of the most common and highly distressing treatment side effects is cancer-related cognitive impairment (CRCI), which is characterized by losses in memory, attention, processing speed, and executive function, which make daily tasks such as recalling information, organizing daily routines, concentrating, and multitasking more challenging. Findings from previous studies support aerobic exercise training as an effective strategy for improving cognitive function. In addition, non-invasive brain stimulation (NIBS), a technique in which electrodes are applied to the skin to noninvasively stimulate specific regions of the brain, has also been found to be a safe and effective approach for improving cognitive outcomes. Among various NIBS techniques, transcranial alternating current stimulation (tACS), which delivers current to the brain in an alternating pattern, may be a promising strategy for improving cognitive outcomes. Few studies have explored these approaches in breast cancer survivors, and to our knowledge, the combination of exercise and tACS (Ex+tACS) has not been explored. This study will assess the feasibility of a 4-week Ex+tACS intervention in breast cancer survivors who report cancer-related cognitive impairment. Researchers will also examine changes in attention, executive function, working memory, perceived cognitive function, and physical function before, after, and four weeks post intervention completion in the Ex+tACS group compared to a control group who will receive exercise and a placebo tACS condition (CON).
Interventions
BEHAVIORALExercise + transcranial alternating current stimulation (Ex+tACS)
The Ex+tACS group will complete a four-week intervention consisting of 3 days/week of 30 minutes of aerobic exercise on a treadmill at a sustained moderate intensity, immediately followed by 15 min of tACS while completing the AX Continuous Performance Test (AX-CPT).
BEHAVIORALControl
The Control (CON) group will complete 30 minutes of aerobic exercise on the treadmill followed by the Sustained Attention-Continuous Performance Task (AX-CPT) with a sham tACS condition. After each session, both the EX+tACS and control participants will complete a questionnaire regarding experience with tACS.
Sponsors
Florida Atlantic University
Memorial Sloan Kettering Cancer Center
Florida Department of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Breast cancer survivors (≥18 years) will be eligible to participate if the following inclusion criteria is met: * Diagnosed non-metastatic breast cancer (stages 0-3) * Completed primary breast cancer treatment (surgery, chemotherapy, radiation) for at least 3 months * Self-reported cognitive impairment after cancer treatment
Exclusion criteria
* Current participation in aerobic exercise for ≥60 min/wk * Contraindication or impairment that precludes the potential participant from exercise as defined by the American College of Sports Medicine * The presence of serious medical illnesses, metal implants, previous brain trauma, epilepsy or history of seizures, previous surgery to the head or spinal cord, or skin problems at the forehead area where the tACS electrodes will be applied * Uncontrolled cardiovascular disease * Functional impairments or physical condition that would make exercise unsafe * Metastatic cancer or diagnosis of a different cancer (excluding melanoma) within the past 5 years * Contraindication to exercise a defined by the American College of Sports Medicine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | From baseline to the end of the 4-week intervention | Adherence will be calculated based on the percentage of prescribed sessions attended and percentage of participants who complete the prescribed exercise and tACS sessions. |
| Retention | From baseline to the end of the 4-week intervention | Retention will be determined by the number of enrolled breast cancer survivors who participate in the four-week intervention and complete post assessments. |
| Acceptability | From baseline to the end of the 4-week intervention | Acceptability will be determined by the percentage of participants who report satisfaction with the intervention. |
| Safety (Adverse Events) | From baseline to the end of the 4-week intervention | Safety (\<5% of serious adverse events) will be determined by the percentage of participants experiencing a serious adverse event related to the program. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained attention | Baseline, within 2 weeks following the intervention, and 4-week follow-up | Researchers will assess pre- to post-intervention changes in sustained attention, measured by performance on the AX-Continuous Performance Test (AX-CPT). |
| Executive function | Baseline, within 2 weeks following the intervention, and 4-week follow-up | Researchers will assess pre- to post-intervention changes in executive function, measured by performance (time) on the Trail Making Test Part A (TMT-A) and Part B (TMT-B). |
| Inhibitory control | Baseline, within 2 weeks following the intervention, and 4-week follow-up | Researchers will assess pre- to post-intervention changes in inhibitory control, measured by performance on the Flanker Compatibility Task. |
| Working Memory | Baseline, within 2 weeks following the intervention, and 4-week follow-up | Researchers will assess pre- to post-intervention changes in working memory, measured by performance on the N-back and Backwards Counting tasks. |
| Subjective Cognition | Baseline, within 2 weeks following the intervention, and 4-week follow-up | Researchers will assess pre- to post-intervention changes in subjective cognition, measured by the Functional Assessment Cancer Therapy-Cognition (FACT-COG) |
| Physical Function | Baseline, within 2 weeks following the intervention, and 4-week follow-up | Researchers will assess pre- to post-intervention changes in lower body physical function, measured by the 30-second chair stand. |
| Cardiorespiratory endurance | Baseline, within 2 weeks following the intervention, and 4-week follow-up | Researchers will assess pre- to post-intervention changes in cardiorespiratory fitness, measured by the six-minute walk test. |
Countries
United States
Contacts
CONTACTAshley L Artese, PhD
Outcome results
None listed