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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasms
• Intervention / Treatment: Behavioral: Aerobic exercise, Strength training, Flexibility exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaeyong Jeon; Phone Number: +82-2-3010-3791; Email: jyjeon71@gmail.com
• Study Contact Backup: Name: Seungwoo Cha; Phone Number: +82-2-3010-3799; Email: miracleofs@naver.com

Study Locations

• Korea, Republic of
  • Seoul Special City
    • Seoul, Seoul Special City, Korea, Republic of, 05505
      • Recruiting
      • Seoul Asan Medical Center
      • Contact: Jaeyong Jeon; Phone Number: +82-10-9970-3791; Email: jyjeon71@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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
No Intervention: Control group; One session of flexibility exercise education, diet management education through nutritional counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bilateral upper limb volume	Using a tape measure, measure the circumference from the wrist to the armpit every 4cm, then apply the ΣCircumference2/π formula to calculate the volume of the upper limb.	Immediately, Preoperatively, 1 month, 3 months, 6 months.
ICG lymphography	Indocyanine green (ICG) contrast agent is injected subcutaneously in the distal area, and lymph fluid flowing to the proximal area through collateral lymphatic vessels is checked with an infrared camera.	Immediately, 1 month, 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	After attaching electrodes to both hands and feet using the Inbody S10 equipment, quantitatively evaluate body composition by measuring human body impedance using multiple frequencies.	Immediately, 6 months.
Shoulder range of motion	Measurements are made according to a standardized protocol using a goniometer.	Immediately, Preoperatively, 1 month, 3 months, 6 months.
Upper limb strength, grip strength	Using a digital hand held dynamometer, the strength of elbow flexion and extension, shoulder abduction, and flexor extensor muscles was measured. Measure grip strength using a digital hand held dynamometer	Immediately, 6 months
EORTC QLQ-C30	Evaluate the patient's quality of life through the corresponding questionnaire	Immediately, 6 months
EORTC QLQ-BR23	Evaluate the patient's quality of life through the corresponding questionnaire	Immediately, 6 months

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Jaeyong Jeon, Asan Medical Center; Study Chair: Heejeong Kim, Asan Medical Center; Study Chair: Seungwoo Cha, Asan Medical Center; Study Chair: Chul Jung, Asan Medical Center; Study Chair: Hwayeong Cheon, Asan Medical Center; Study Chair: Junghwa Do, Asan Medical Center; Study Chair: Woojin Jeong, Asan Medical Center; Study Chair: Doyoung Kim, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Lymphedema; Breast Cancer; Preoperative Exercise
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Lymphatic Diseases; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: 2024-0255

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No