Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients

NCT ID: NCT06421285

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2025-12-31

Brief Summary

Research purpose: Lymphedema is a very common complication in breast cancer patients. However, since there is currently no curable treatment, it is important to prevent and reduce the severity of lymphedema. The purpose of this study is to evaluate whether preoperative exercise is effective in preventing lymphedema after surgery. For secondary outcome, the preventive effects of exercise on other upper extremity dysfunctions (eg. pectoralis tightness, Axillary web syndrome, Adhesive capsulitis), which are common in breast cancer patients, were assessed.

Detailed Description

Study subjects:

• Patients aged 20 or older who were first diagnosed with breast cancer
• Patients scheduled to undergo neoadjuvant chemotherapy before surgery Study design: Prospective randomized controlled comparative clinical study
• Intervention is performed for at least 3 months during the neoadjuvant chemotherapy period before surgery.
• Treatment group: Individually tailored exercise consisting of aerobic, strength, and flexibility exercises is prescribed, self-exercise compliance monitoring through an application, and diet management education through nutritional counseling.
• Control group: One session of flexibility exercise training, diet management education through nutritional counseling

Result variable:

• Primary outcome variable:

1) Incidence and severity of postoperative lymphedema: bilateral upper limb volume, ICG lymphography

• Secondary outcome variables:

1. Clinical information: Demographic, disease and treatment-related data

2. Physical-related: height/weight/waist circumference measurement, body composition test, physical examination (axillary membrane evaluation)

3. Upper extremity function (shortening of the pectoralis major muscle, adhesive capsulitis): evaluation of shoulder range of motion, upper extremity muscle strength/grip strength

4. Quality of life assessment: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast cancer module 23(EORTC QLQ-BR23)

Assessment Schedule:

• Initial treatment and evaluation: Immediately after breast cancer diagnosis
• Follow-up evaluation: Immediately after completion of exercise intervention (preoperatively), and at 1, 3, and 6 months postoperatively.

Number of study subjects:

• This study will be conducted as a preliminary study for future research, and will be conducted on a total of 60 patients (30 in the experimental group and 30 in the control group) with an allocation ratio between groups of 1:1.

Conditions

Breast Neoplasms

Study Design

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

Study Groups

Intervention group

Individually tailored exercise consisting of aerobic, strength, and flexibility exercises is prescribed, self-exercise compliance monitoring through an application, and diet management education through nutritional counseling.

Group Type: EXPERIMENTAL

Aerobic exercise, Strength training, Flexibility exercise

Intervention Type: BEHAVIORAL

Aerobic exercise: 30-40 minutes/time, 3-5 times a week, intensity of 4-6 points on the Rating of Perceived Exertion(RPE) 10-point scale(A simple conversation is possible during exercise, but the intensity is such that you feel out of breath) Strength training: 2-3 times a week, 3 sets of 10 repetitions per movement

• Upper extremities: Biceps brachii, triceps brachii, deltoid, pectoralis muscle exercise
• Lower extremities: gluteus maximus, hamstrings, quadriceps exercise Flexibility exercise: Stretching and mobility exercises reflecting post-surgery rehabilitation

Control group

One session of flexibility exercise education, diet management education through nutritional counseling

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aerobic exercise, Strength training, Flexibility exercise

Aerobic exercise: 30-40 minutes/time, 3-5 times a week, intensity of 4-6 points on the Rating of Perceived Exertion(RPE) 10-point scale(A simple conversation is possible during exercise, but the intensity is such that you feel out of breath) Strength training: 2-3 times a week, 3 sets of 10 repetitions per movement

• Upper extremities: Biceps brachii, triceps brachii, deltoid, pectoralis muscle exercise
• Lower extremities: gluteus maximus, hamstrings, quadriceps exercise Flexibility exercise: Stretching and mobility exercises reflecting post-surgery rehabilitation

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients aged 20 or older and younger than 80 who were first diagnosed with breast cancer
• Patients scheduled for surgery and starting neoadjuvant chemotherapy before surgery

Exclusion Criteria

• Patients with medical contraindications to exercise intervention or pain or musculoskeletal conditions that may limit active exercise intervention

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jae Yong Jeon, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaeyong Jeon

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Heejeong Kim

Role: STUDY_CHAIR

Asan Medical Center

Seungwoo Cha

Role: STUDY_CHAIR

Asan Medical Center

Chul Jung

Role: STUDY_CHAIR

Asan Medical Center

Hwayeong Cheon

Role: STUDY_CHAIR

Asan Medical Center

Junghwa Do

Role: STUDY_CHAIR

Asan Medical Center

Woojin Jeong

Role: STUDY_CHAIR

Asan Medical Center

Doyoung Kim

Role: STUDY_CHAIR

Asan Medical Center

Locations

Seoul Asan Medical Center

Seoul, Seoul Special City, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jaeyong Jeon

Role: CONTACT

jyjeon71@gmail.com

+82-2-3010-3791

Seungwoo Cha

Role: CONTACT

miracleofs@naver.com

+82-2-3010-3799

Facility Contacts

Jaeyong Jeon

Role: primary

jyjeon71@gmail.com

+82-10-9970-3791

Other Identifiers

2024-0255

Identifier Type: -

Identifier Source: org_study_id