Aerobic Dance During Chemotherapy in Breast Cancer Patients With Cognitive Impairment

NCT ID: NCT06234150

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2027-01-01

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aerobic dance

50 minutes of moderate-intensity aerobic dance three times a week

Group Type: EXPERIMENTAL

Aerobic dance

Intervention Type: OTHER

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 using the PRE and heart rate, and the presence of adverse effects. An experienced physical therapist will remotely supervise patients via teleconferencing at home. They will exercise for 50 min three times per week for 12 weeks. The physiotherapist monitors the patient\'s heart rate throughout the exercise program and provides feedback on any problems encountered during exercise.

Fast-walking

50 minutes of moderate-intensity fast walking three times a week

Group Type: EXPERIMENTAL

Fast-walking

Intervention Type: OTHER

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 using the PRE and heart rate, and the presence of adverse effects. An experienced physical therapist will remotely supervise patients via teleconferencing at home. They will exercise for 50 min three times per week for 12 weeks. The physiotherapist monitors the patient\'s heart rate throughout the exercise program and provides feedback on any problems encountered during exercise.

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 using the PRE and heart rate, and the presence of adverse effects. An experienced physical therapist will remotely supervise patients via teleconferencing at home. They will exercise for 50 min three times per week for 12 weeks. The physiotherapist monitors the patient\'s heart rate throughout the exercise program and provides feedback on any problems encountered during exercise.

Intervention Type: 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 using the PRE and heart rate, and the presence of adverse effects. An experienced physical therapist will remotely supervise patients via teleconferencing at home. They will exercise for 50 min three times per week for 12 weeks. The physiotherapist monitors the patient\'s heart rate throughout the exercise program and provides feedback on any problems encountered during exercise.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Yi Zhu

Role: CONTACT

ZhuYi1981@njmu.edu.cn

+8613705164030

Yuqi Cheng

Role: CONTACT

chengyuqi810@stu.njmu.edu.cn

+8615656096379

Facility Contacts

Yun Liu

Role: primary

liuyun@njmu.edu.cn

025-83714511

References

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.

Reference Type: DERIVED

PMID: 41106863 (View on PubMed)

Other Identifiers

2023-SR-732

Identifier Type: OTHER

Identifier Source: secondary_id

2023-SR-732

Identifier Type: -

Identifier Source: org_study_id