Breast NeoplasmsADANCNCT06234150
Aerobic Dance During Chemotherapy in Breast Cancer Patients With Cognitive Impairment
A study testing Aerobic dance and Fast-walking in people with Breast Neoplasms and Exercise Therapy, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Neoplasms, Exercise Therapy, Chemotherapy-Related Cognitive Impairment
- What is being tested?
- Aerobic dance and Fast-walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Yun Liu, 025-83714511, liuyun@njmu.edu.cn
Lu Xu
About this study
Official title: 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.
Read the 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
- Being tested
- Aerobic dance, Fast-walking
- Medical subject headings
- Breast Neoplasms, Chemotherapy-Related Cognitive Impairment, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic danceOther
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-walkingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic dance | Experimental | 50 minutes of moderate-intensity aerobic dance three times a week Receives: Other: Aerobic dance |
| Fast-walking | Experimental | 50 minutes of moderate-intensity fast walking three times a week Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (6)
the Auditory Word Learning Test - Huashan (AVLT-H)
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.
Measured: From enrollment to the end of treatment at 12 weeks
Montreal cognitive assessment-basic (MOCA-B)
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.
Measured: From enrollment to the end of treatment at 12 weeks
Verbal fluency test (VFT)
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.
Measured: From enrollment to the end of treatment at 12 weeks
The functional Assessment of Cancer Therapy-Cognitive Function(FACT-Cog)
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.
Measured: From enrollment to the end of treatment at 12 weeks
the Functional Assessment of Cancer Therapy-Breast (FACT-B)
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.
Measured: From enrollment to the end of treatment at 12 weeks
he Hospital Anxiety and Depression Scale（HADS）
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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234150
- Sponsor's protocol ID
- 2023-SR-732
- Other IDs
- 2023-SR-732
- Acronym
- ADANC
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 41106863
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Dance During Chemotherapy in Breast Cancer Patients With Cognitive Impairment（ADANC）
- ClinicalTrials.gov ID
- NCT06234150
- Acronym / sponsor ID
- ADANC / 2023-SR-732
- Conditions
- Breast Neoplasms, Exercise Therapy, Chemotherapy-Related Cognitive Impairment, Cognitive Dysfunction, Dance Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic dance | Experimental | Other: Aerobic dance50 minutes of moderate-intensity aerobic dance three times a week |
| Fast-walking | Experimental | Other: Fast-walking50 minutes of moderate-intensity fast walking three times a week |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic dancePatients 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. | Other | Aerobic dance |
| Fast-walkingPatients 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. | Other | Fast-walking |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 41106863Cheng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic dance and Fast-walking in people with Breast Neoplasms and Exercise Therapy, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhu (+8613705164030, ZhuYi1981@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shape Trail Test (STT) (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06234150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.