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

February 17, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • The First Affiliated Hospital of Nanjing medical University
        • Principal Investigator:
          • Jue Wang
        • Contact:
        • Principal Investigator:
          • Lu Xu
        • Sub-Investigator:
          • Nan Xia
        • Principal Investigator:
          • Jianjie Qin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic dance
50 minutes of moderate-intensity aerobic dance three times a week
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 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.
Experimental: Fast-walking
50 minutes of moderate-intensity fast walking three times a week
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shape Trail Test (STT)
Time Frame: From enrollment to the end of treatment at 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Auditory Word Learning Test - Huashan (AVLT-H)
Time Frame: From enrollment to the end of treatment at 12 weeks
A scale to test memory function in which the tester reads out 12 words after informing the subject that they need to recall them, and the subject recalls, learns, and recalls the words three times in a row immediately after hearing them, short delayed recall, long-delayed recall, categorical cue recall, and recognition, and the number of words recalled is recorded. Higher scores represent better memory.
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
The Montreal Cognitive Assessment-Basic (MoCA-B) assesses the patient's overall cognitive function. The scale is simple and easy to use and covers several cognitive domains, including attention, executive function, memory, language, visuospatial ability, etc. The higher the score, the better the cognitive function.
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 number of animal names uttered by the participant within 1 minute is recorded. The more the animal' name is spoken, the better the verbal fluency.
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
Health-related quality of life is assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 37-item questionnaire designed specifically for breast cancer patients that measures the following five domains: physical, social, emotional, and functional well-being, as well as breast cancer subscales. 3. Sleep quality: assessed using the Pittsburgh Sleep Quality Index, a 19-item questionnaire that assesses seven subjects' sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, sleep medication use, and daytime dysfunction, provides an overall score.
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
a self-report scale usually consisting of 14 entries, of which seven rate depression and seven rate anxiety. It is widely used in studies of psychosomatic disorders and has good reliability and validity. Higher scores indicate severe anxiety-depression symptoms.
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 Assessment of Cognitive Functioning in Cancer Therapy (FACT-Cog) is a comprehensive scale that assesses self-reported cognitive functioning and consists of the following four sections, Perceived Cognitive Impairment (Cog-PCI), Perceived Cognitive Ability (Cog-PCA), Quality of Life Impacted by Cognitive Impairment (Cog-QoL), and Cognitive Impairment as Perceived by Others (Cog-Oth) for a total of 37 items, with a score of 4 points each. Each item is scored out of 4. The higher the score, the better the self-reported cognitive functioning.
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-SR-732 (Other Identifier: Ethics Committee of Nanjing Medical University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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