Clinical trial NCT06234150: Aerobic Dance During Chemotherapy in Breast Cancer Patients With Cognitive Impairment
Official title: Aerobic Dance During Chemotherapy in Breast Cancer Patients With Cognitive Impairment（ADANC）
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Exercise Therapy
Chemotherapy-Related Cognitive Impairment
Cognitive Dysfunction
Dance Therapy
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Shape Trail Test (STT)
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: the Auditory Word Learning Test - Huashan (AVLT-H)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Montreal cognitive assessment-basic (MOCA-B)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Verbal fluency test (VFT)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: The functional Assessment of Cancer Therapy-Cognitive Function(FACT-Cog)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: the Functional Assessment of Cancer Therapy-Breast (FACT-B)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: he Hospital Anxiety and Depression Scale（HADS）
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References: