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NCT Number: NCT06421285

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul Asan Medical Center

Seoul, Seoul Special City, 05505, South Korea

Location status: Recruiting

Location contact

Jaeyong Jeon

CONTACT

[email protected]

+82-10-9970-3791

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic exercise, Strength training, Flexibility exercise

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Body composition

    Time frame: Immediately, 6 months.

    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.

  2. Shoulder range of motion

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

    Measurements are made according to a standardized protocol using a goniometer.

  3. Upper limb strength, grip strength

    Time frame: Immediately, 6 months

    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

  4. EORTC QLQ-C30

    Time frame: Immediately, 6 months

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

  5. EORTC QLQ-BR23

    Time frame: Immediately, 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jaeyong Jeon

CONTACT

[email protected]

+82-2-3010-3791

Seungwoo Cha

CONTACT

[email protected]

+82-2-3010-3799

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 20, 2024
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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