Aerobic Dance During Chemotherapy in Breast Cancer Patients With Cognitive Impairment（ADANC）
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Shape Trail Test (STT)
研究概览
简要总结
The goal of this clinical trial is to learn about breast cancer patients. The main questions it aims to answer are:
- Does Aerobic Dance During Chemotherapy Improve Cognitive Function in Breast Cancer Patients？
- Does the efficacy of aerobic dance differ from fast walking of equal intensity？ Recruited patients will be randomly assigned to three groups: (1) aerobic dance group, (2) fast walking group, and (3) usual care group.
The aerobic dance and fast-walking groups participated in supervised exercise lasting 50 minutes thrice a week for 12 weeks.
The goal of this study's findings is to develop practical strategies for managing breast cancer-related cognitive impairment.
详细描述
BACKGROUND: Cancer-related cognitive impairment (CRCI) is often reported in breast cancer patients and is characterized by a decline in cognitive functions including memory, processing speed, attention, and executive function. Despite the fact that chemotherapy is a significant cause of CRCI, recent studies have shown that 20-30% of patients may already have cognitive decline prior to chemotherapy and that chemotherapy may exacerbate cognitive impairment in these patients. These findings highlight the importance of providing these patients with appropriate interventions while undergoing chemotherapy. A comprehensive form of aerobic exercise known as aerobic dancing has been demonstrated to be effective in alleviating mild cognitive impairment; however, its potential to alleviate cancer-related cognitive impairment is still unknown.
OBJECTIVE
To examine the effects of both aerobic exercises on cognitive function during chemotherapy and compare whether aerobic dance differs from fast walking at the same intensity METHODS: In this three-arm randomized controlled trial, 90 breast cancer patients scheduled for chemotherapy will be randomly assigned to one of three groups: aerobic dance, fast walking, or usual care. The aerobic dance group will participate in three weekly sessions of supervised moderate-intensity exercise, lasting fifty minutes each, for twelve weeks. In contrast, the fast walking group receives the same level of fast-walking intervention, but the usual care group receives no exercise interventions.
RESULTS: The study used the cognitive scales recommended by the International Cognition and Cancer Task Force (ICCTF) with slight modifications for Chinese. The study also included self-reported cognitive function, and assessments on anxiety and depression, quality of life, and sleep. Lymphedema and anthropometry were also included as exploratory indicators.
CONCLUSION: This first-of-its-kind study integrates a novel exercise intervention (Aerobic Dance) with extensive cognitive assessments. If the results are positive, they will serve as a helpful guide for physicians and psychologists to provide women with breast cancer with a comprehensive treatment plan.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •Newly diagnosed, histologically confirmed, resected stage I-IIIa BC
- •Scheduled for chemotherapy with Epirubicin+ Cyclophosphamide (EC) regimen
- •Presence of objective cognitive decline
排除标准
- •Regular exercise habits (exercise at moderate intensity for 30 minutes a day, 3 days a week, for at least 3 months.),
- •Motor dysfunction
- •Alzheimer's disease
- •Vascular dementia
结局指标
主要结局
Shape Trail Test (STT)
时间窗: From enrollment to the end of treatment at 12 weeks
Chinese version of the Shape Test (STT-A, STT-B). This test is widely used in China to assess a person's executive function. The Tracking Test (TMT) was created by Partington in 1938. It is divided into two parts, A and B. In part A, the subject must connect 25 numbers on a piece of paper in a specific order; in part B, the subject must connect 25 numbers and letters in alternating order. Since some Chinese may not be familiar with the English alphabet, we used the Chinese version of round and square numbers. The numbers should be connected in sequence, alternating between different shapes. This helps to test the subject's ability to transfer stereotypes, hand-eye coordination, spatial perception and memory. The faster the response, the higher the sensitivity.
次要结局
- the Auditory Word Learning Test - Huashan (AVLT-H)(From enrollment to the end of treatment at 12 weeks)
- Montreal cognitive assessment-basic (MOCA-B)(From enrollment to the end of treatment at 12 weeks)
- Verbal fluency test (VFT)(From enrollment to the end of treatment at 12 weeks)
- The functional Assessment of Cancer Therapy-Cognitive Function(FACT-Cog)(From enrollment to the end of treatment at 12 weeks)
- the Functional Assessment of Cancer Therapy-Breast (FACT-B)(From enrollment to the end of treatment at 12 weeks)
- he Hospital Anxiety and Depression Scale（HADS）(From enrollment to the end of treatment at 12 weeks)