Breast NeoplasmsNCT06421285
Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients
A study testing Aerobic exercise, Strength training, Flexibility exercise in people with Breast Neoplasms, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Aerobic exercise, Strength training, Flexibility exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with medical contraindications to exercise intervention or pain or musculoskeletal conditions that may limit active exercise intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul Asan Medical Center
Seoul, Seoul Special City, 05505
Jaeyong Jeon, +82-10-9970-3791, jyjeon71@gmail.com
About this study
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:
- Incidence and severity of postoperative lymphedema: bilateral upper limb volume, ICG lymphography
- Secondary outcome variables:
- Clinical information: Demographic, disease and treatment-related data
- Physical-related: height/weight/waist circumference measurement, body composition test, physical examination (axillary membrane evaluation)
- Upper extremity function (shortening of the pectoralis major muscle, adhesive capsulitis): evaluation of shoulder range of motion, upper extremity muscle strength/grip strength
- 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
- Being tested
- Aerobic exercise, Strength training, Flexibility exercise
- Keywords
- Preoperative Exercise, Lymphedema, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise, Strength training, Flexibility exerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Aerobic exercise, Strength training, Flexibility exercise |
| Control group | No intervention | One session of flexibility exercise education, diet management education through nutritional counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately, 1 month, 6 months.
Secondary outcomes (5)
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.
Measured: Immediately, 6 months.
Shoulder range of motion
Measurements are made according to a standardized protocol using a goniometer.
Measured: 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
Measured: Immediately, 6 months
EORTC QLQ-C30
Evaluate the patient's quality of life through the corresponding questionnaire
Measured: Immediately, 6 months
EORTC QLQ-BR23
Evaluate the patient's quality of life through the corresponding questionnaire
Measured: Immediately, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start10 Jan 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Intervention group * Control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Yong Jeon, MD, Asan Medical Center
- Investigators
- Jaeyong Jeon, Principal investigator, Asan Medical CenterHeejeong Kim, Study chair, Asan Medical CenterSeungwoo Cha, Study chair, Asan Medical CenterChul Jung, Study chair, Asan Medical CenterHwayeong Cheon, Study chair, Asan Medical CenterJunghwa Do, Study chair, Asan Medical CenterWoojin Jeong, Study chair, Asan Medical CenterDoyoung Kim, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421285
- Sponsor's protocol ID
- 2024-0255
- Status last verified
- Jun 2025
- First submitted
- 10 May 2024
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06421285
- Acronym / sponsor ID
- 2024-0255
- Conditions
- Breast Neoplasms
- Keywords
- Preoperative Exercise, Lymphedema, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Incidence and severity of postoperative lymphedema: bilateral upper limb volume, ICG lymphography
- Secondary outcome variables:
- Clinical information: Demographic, disease and treatment-related data
- Physical-related: height/weight/waist circumference measurement, body composition test, physical examination (axillary membrane evaluation)
- Upper extremity function (shortening of the pectoralis major muscle, adhesive capsulitis): evaluation of shoulder range of motion, upper extremity muscle strength/grip strength
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- * Intervention group * Control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Aerobic exercise, Strength training, Flexibility exerciseIndividually 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 | No intervention | –One session of flexibility exercise education, diet management education through nutritional counseling |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with medical contraindications to exercise intervention or pain or musculoskeletal conditions that may limit active exercise intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise, Strength training, Flexibility exerciseAerobic 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 | Behavioural | Intervention group |
Primary outcome
Bilateral upper limb volume
Time frame: Immediately, Preoperatively, 1 month, 3 months, 6 months.
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.
ICG lymphography
Time frame: Immediately, 1 month, 6 months.
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.
5 secondary outcomes
Body composition
Time frame: Immediately, 6 months.
Shoulder range of motion
Time frame: Immediately, Preoperatively, 1 month, 3 months, 6 months.
Upper limb strength, grip strength
Time frame: Immediately, 6 months
EORTC QLQ-C30
Time frame: Immediately, 6 months
EORTC QLQ-BR23
Time frame: Immediately, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaeyong Jeon principal investigator
Asan Medical Center
Heejeong Kim study chair
Asan Medical Center
Seungwoo Cha study chair
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise, Strength training, Flexibility exercise in people with Breast Neoplasms, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaeyong Jeon (+82-2-3010-3791, jyjeon71@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral upper limb volume (time frame: Immediately, Preoperatively, 1 month, 3 months, 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.