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RecruitingNCT06421285Updated Jun 29, 2025

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

An interventional study of Aerobic exercise, Strength training, Flexibility exercise in Breast Neoplasms, sponsored by Asan Medical Center. Recruiting at 1 site in South Korea. Open to female participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-29.

Sponsored by Asan Medical Center · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Breast Neoplasms

Keywords

  • Preoperative Exercise
  • Lymphedema
  • Breast Cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with medical contraindications to exercise intervention or pain or musculoskeletal conditions that may limit active exercise intervention
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • No intervention
    Control group

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

Interventions

  • BehavioralAerobic 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately, Preoperatively, 1 month, 3 months, 6 months.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. EORTC QLQ-C30

    Evaluate the patient's quality of life through the corresponding questionnaire

    Time frame: Immediately, 6 months

  5. EORTC QLQ-BR23

    Evaluate the patient's quality of life through the corresponding questionnaire

    Time frame: Immediately, 6 months

07

Study locations

1 of 1 sites recruiting
  • Seoul Asan Medical Center
    Seoul, Seoul Special City 05505, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06421285
Lead sponsor
Asan Medical Center
Responsible party
Jae Yong Jeon, MD (Professor, Asan Medical Center) — Principal investigator
First posted
May 20, 2024
Start date
Jan 10, 2025
Primary completion
Oct 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jun 29, 2025

Study contacts

Jaeyong Jeon
Contact
jyjeon71@gmail.com
+82-2-3010-3791
Seungwoo Cha
Contact
miracleofs@naver.com
+82-2-3010-3799
Jaeyong Jeon
principal investigator · Asan Medical Center
Heejeong Kim
study chair · Asan Medical Center
Seungwoo Cha
study chair · Asan Medical Center
Chul Jung
study chair · Asan Medical Center
Hwayeong Cheon
study chair · Asan Medical Center
Junghwa Do
study chair · Asan Medical Center
Woojin Jeong
study chair · Asan Medical Center
Doyoung Kim
study chair · Asan Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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