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

N

Nanjing Medical University

Status

Not yet enrolling

Conditions

Chemotherapy-Related Cognitive Impairment
Exercise Therapy
Dance Therapy
Cognitive Dysfunction
Breast Neoplasms

Treatments

Other: Aerobic dance
Other: Fast-walking

Study type

Interventional

Funder types

Other

Identifiers

NCT06234150
2023-SR-732 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 3 patient groups

Aerobic dance
Experimental group
Description:
50 minutes of moderate-intensity aerobic dance three times a week
Treatment:
Other: Aerobic dance
Fast-walking
Experimental group
Description:
50 minutes of moderate-intensity fast walking three times a week
Treatment:
Other: Fast-walking
Usual care
No Intervention group
Description:
Maintain the usual lifestyle and receive medical treatment as normal as the rest of the group.After the baseline evaluation, participants in the control group are asked to maintain their regular lifestyle, including their level of physical activity, and to continue receiving medical treatment and care by standard procedures for 12 weeks. The control group did not receive any encouragement from the researcher to increase the time they spent exercising because, at the time of patient data collection, they were not routinely informed about the benefits of exercise during chemotherapy. Control patients were allowed to engage in the same experimental exercise condition after the 24-week study cycles; if they declined, the study would be stopped.

Trial contacts and locations

1

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Central trial contact

Yi Zhu; Yuqi Cheng

Data sourced from clinicaltrials.gov

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