Aerobic Dance During Chemotherapy in Breast Cancer Patients With Cognitive Impairment

Официальное название

Aerobic Dance During Chemotherapy in Breast Cancer Patients With Cognitive Impairment（ADANC）

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Aerobic dance
  Patients assigned to the aerobic dance group will participate in a one-on-one training session before their first chemotherapy session, including aerobic dance instruction, teleconference participation, use of a heart rate bracelet, and use of the Perceived Exertion Rating (PRE) until they master all components. The researchers will also provide participants with instructional videos to view anytime. We will require an exercise log to record the number of workouts, the intensity of the workout u
• Другое Fast-walking
  Patients assigned to the fast-walking group will participate in a one-on-one training session before their first chemotherapy session, including fast-walking instruction, teleconference participation, use of a heart rate bracelet, and use of the Perceived Exertion Rating (PRE) until they master all components. The researchers will also provide participants with instructional videos to view anytime. We will require an exercise log to record the number of workouts, the intensity of the workout usi

Первичные конечные точки

• Shape Trail Test (STT) [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (6)

• the Auditory Word Learning Test - Huashan (AVLT-H) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Montreal cognitive assessment-basic (MOCA-B) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Verbal fluency test (VFT) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• The functional Assessment of Cancer Therapy-Cognitive Function(FACT-Cog) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• the Functional Assessment of Cancer Therapy-Breast (FACT-B) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• he Hospital Anxiety and Depression Scale（HADS） [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Nanjing Medical University — Нанкин

Публикации

• Cheng Y, Xu L, Xia N, Wang J, Yang W, Jin C, Wang R, Qin J, Zhu Y. Aerobic dance during chemotherapy in patients with breast cancer with cognitive impairment (ADANC): protocol for an assessor-blinded randomised clinical trial. BMJ Open. 2025 Oct 17;15(10):e092003. doi: 10.1136/bmjopen-2024-092003. PMID 41106863

Идентификаторы

NCT: NCT06234150 · 2023-SR-732 · 2023-SR-732

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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