Aerobic Dance During Chemotherapy in Breast Cancer Patients With Cognitive Impairment

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Other 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
• Other 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

Primary outcome measures

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

Secondary outcome measures (6)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Nanjing Medical University — Nanjing

Publications

• 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

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗