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

NCT06421285 | Recruiting

• 1 other identifier: 2024-0255
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasms

Keywords

Preoperative Exercise; Lymphedema; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Body composition

  Immediately, 6 months.

• Shoulder range of motion

  Immediately, Preoperatively, 1 month, 3 months, 6 months.

• Upper limb strength, grip strength

  Immediately, 6 months

• EORTC QLQ-C30

  Immediately, 6 months

• EORTC QLQ-BR23

  Immediately, 6 months

Study Arms (2)

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.

Behavioral: Aerobic exercise, Strength training, Flexibility exercise

Control group

NO INTERVENTION

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

Interventions

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

Intervention group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Seoul Asan Medical Center

Seoul, Seoul Special City, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Jaeyong Jeon

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Central Study Contacts

Jaeyong Jeon

CONTACT

+82-2-3010-3791; jyjeon71@gmail.com

Seungwoo Cha

CONTACT

+82-2-3010-3799; miracleofs@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: * Patients aged 20 or older and younger than 80 years old who were first diagnosed with breast cancer * Patients scheduled to undergo neoadjuvant chemotherapy before surgery
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: * Intervention group * Control group

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 20, 2024
• Study Start: January 10, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)