Aerobic Dance During Chemotherapy in Breast Cancer Patients With Cognitive Impairment

NCT06234150 | Not Yet Recruiting

• 1 other identifier: 2023-SR-732
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Shape Trail Test (STT)

  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.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (6)

• 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

Study Arms (3)

Aerobic dance

EXPERIMENTAL

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

Other: Aerobic dance

Fast-walking

EXPERIMENTAL

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

Other: Fast-walking

Usual care

NO INTERVENTION

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.

Interventions

Aerobic dance 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.

Aerobic dance

Fast-walking 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.

Fast-walking

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Newly diagnosed, histologically confirmed, resected stage I-IIIa BC
• Scheduled for chemotherapy with Epirubicin+ Cyclophosphamide (EC) regimen
• Presence of objective cognitive decline

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Chemotherapy-Related Cognitive Impairment; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Yi Zhu

CONTACT

+8613705164030; ZhuYi1981@njmu.edu.cn

Yuqi Cheng

CONTACT

+8615656096379; chengyuqi810@stu.njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: January 31, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CN (1)