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 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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
60
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
Seoul Asan Medical Center
Seoul, Seoul Special City, South Korea
RECRUITINGBilateral 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.
Time frame: 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.
Time frame: Immediately, 1 month, 6 months.
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.
Time frame: Immediately, 6 months.
Shoulder range of motion
Measurements are made according to a standardized protocol using a goniometer.
Time frame: 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
Time frame: Immediately, 6 months
EORTC QLQ-C30
Evaluate the patient's quality of life through the corresponding questionnaire
Time frame: Immediately, 6 months
EORTC QLQ-BR23
Evaluate the patient's quality of life through the corresponding questionnaire
Time frame: Immediately, 6 months
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