Aerobic Exercise and Cognitive Functioning in Women With Breast Cancer: the ACTIVATE Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 5
- 主要终点
- Change with treatment and maintenance post-treatment in objective neuropsychology test battery composite score
研究概览
简要总结
In Canada, approximately 68 women are diagnosed with breast cancer every day. Chemotherapy-related cognitive changes (CRCC) are reported by up to 75% of breast cancer survivors during treatment and symptoms persist in 35% of survivors after treatment. Women report that CRCC negatively impacts their everyday functioning and substantially reduces their overall quality of life. Effective clinical interventions to manage CRCC are elusive. As a result, breast cancer survivors typically receive little to no advice on how to prevent or manage CRCC. Aerobic exercise is a type of physical activity that uses large muscle groups, is rhythmic in nature, and can be sustained for at least 10 minutes (e.g., walking, jogging, indoor cycling). It has been associated with improved quality of life in breast cancer survivors. It also holds great promise as an intervention to prevent or mitigate CRCC. However, there is limited evidence from experimental studies to confirm this. Therefore, the primary aim of this trial is to evaluate the impact of a supervised aerobic exercise intervention on CRCC in women diagnosed with early-stage breast cancer. Recruited women will be randomized into one of two groups: (1) aerobic exercise during chemotherapy, or (2) usual care during chemotherapy and the aerobic exercise post-chemotherapy (i.e., wait-list control group). This study will test several novel hypotheses, including whether exercise during chemotherapy can prevent and/or mitigate CRCC and its negative impact on quality of life among women with breast cancer, and whether the timing of the exercise intervention matters (i.e., exercise during versus after chemotherapy). The results of this study aim to address the concerns of women affected by CRCC who are currently lacking available evidence-based treatment options, as well as oncology care providers' need to have options to recommend to their patients to prevent or manage CRCC.
详细描述
The purpose of this study is to evaluate the impact of an aerobic exercise intervention on CRCC in women diagnosed with breast cancer who undergo chemotherapy. The specific objectives are to:
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Test the effect of aerobic exercise during chemotherapy (EX) compared to a usual care wait-list control group (exercise after chemotherapy; UC) on CRCC as assessed by neuropsychological tests and self-report;
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Test the effect of EX compared to UC on:
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Global measures of brain structure and functioning including brain volume in regions associated with working memory and response inhibition, white matter integrity (i.e., fractional anisotropy, mean diffusivity), and neural functioning using magnetic resonance imaging (MRI);
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Overall global brain network organization and improved regional brain network organization and neural functioning in areas underlying attention and working memory (i.e., dorso-lateral prefrontal cortex, superior temporal region and posterior parietal cortex) using electroencephalography (EEG; Vancouver site only; see Methods).
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Assess if the timing of the exercise intervention (i.e., during chemotherapy versus after chemotherapy) moderates the effects on CRCC by examining the effects of the intervention at 1-year post start of chemotherapy.
It is hypothesized that:
- At the end of chemotherapy, EX group will perform better than UC group on neuropsychological tests and will self-report better cognitive functioning;
- At the end of chemotherapy, EX group will have maintained measures of brain structure and functioning as assessed by MRI scans and EEG (Vancouver site only) compared to UC group who will have significant changes in both;
- At 1-year post the start of chemotherapy, EX group will have better outcomes compared to the UC group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with stage I-III breast cancer;
- •Scheduled to receive adjuvant or neoadjuvant chemotherapy;
- •Able to speak and understand English in order to complete the study outcome measures;
- •Approval of medical oncologist to participate in the exercise intervention
排除标准
- •Having previously received chemotherapy or radiation therapy;
- •Score <24 at baseline on the Montreal Cognitive Assessment (MoCA; indicating moderate to severe cognitive impairment);
- •Having received a diagnosis of severe anxiety or mood disorder within the past year;
- •Having a medical condition that could impact cognition (e.g., prior head injury, substance use disorder);
- •Currently meeting American College of Sports Medicine (ACSM) aerobic exercise guidelines for cancer survivors in the 3 months prior to enrolment;
- •Body mass index ≥45 kg/m2;
- •Mobility issues that require a mobility aid or that prevent exercise on a bike, treadmill, or elliptical (e.g., orthopedic injury, severe arthritis).
- •Additional Inclusion/Exclusion Criteria: During the screening process, patients will be informed that they can participate in additional optional assessments (i.e., MRI and EEG (Vancouver site only for EEG)
- •Additional inclusion criteria for MRI:
- •Right-handedness, because language is lateralized and has been shown to be left side dominant (for right handers) during MRI tasks;
- •Able to read, understand, and provide informed consent in English for the additional assessments.
- •Additional exclusion criteria for MRI are:
- •Metal implants (e.g., pacemaker) or metal dental work (aside from fillings) that would preclude scanning;
- •Claustrophobia;
- •Poor eyesight (not correctable with contact lenses) that precludes viewing stimuli presented in the scanner;
- •Lower back pain that would preclude a person from lying relatively still for one hour;
- •Breast tissue expander(s) inserted in the surgery site.
结局指标
主要结局
Change with treatment and maintenance post-treatment in objective neuropsychology test battery composite score
时间窗: Pre-chemotherapy (baseline, week 0), end of chemotherapy (12-18 weeks post-baseline), follow-up/post-usual care group receiving intervention (24-34 weeks post-baseline), 1-year follow-up (52 weeks post-baseline)
A neuropsychological test battery. The tests are as follows: WAIS-IV (Digit-Symbol Coding, Letter-Number-Sequencing), Auditory Consonant Trigrams Test, Brief Visuospatial Memory Test Revised, Controlled Oral Word Association Test, Hopkins Verbal Learning Test-Revised, and Trail Making Test A\&B. Alternate forms will be used, with the exception of the WAIS-IV tests, the Controlled Oral Word Association Test, and Trail Making A\&B. These tests are combined to form a composite score called the COGSUM.
次要结局
- Change with treatment and maintenance post-treatment in self-reported cognitive function and impact on quality of life(Pre-chemotherapy (baseline, week 0), mid-chemotherapy (week 6-9), end of chemotherapy (12-18 weeks post-baseline), follow-up/post-usual care group receiving intervention (24-34 weeks post-baseline), 1-year follow-up (52 weeks post-baseline).)
- Change with treatment and maintenance post-treatment in brain function and structure(Pre-chemotherapy (baseline, week 0), end of chemotherapy (12-18 weeks post-baseline), 1-year follow-up (52 weeks post-baseline).)
- Change with treatment and maintenance post-treatment in electrical activity of the brain(Pre-chemotherapy (baseline, week 0), end of chemotherapy (12-18 weeks post-baseline), 1-year follow-up (52 weeks post-baseline).)
- Change with treatment and maintenance post-treatment in self-reported cognitive function(Pre-chemotherapy (baseline, week 0), mid-chemotherapy (week 6-9), end of chemotherapy (12-18 weeks post-baseline), follow-up/post-usual care group receiving intervention (24-34 weeks post-baseline),1-year follow-up (52 weeks post-baseline).)
研究者
Kristin Campbell
Associate Professor
University of British Columbia