## Protocol Section
### Identification Module
**NCT ID:** NCT06421285

**Brief Title:** Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients

**Official Title:** Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients

#### Organization Study ID Info
**ID:** 2024-0255
#### Organization
**Class:** OTHER
**Full Name:** Asan Medical Center
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-27

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Asan Medical Center

#### Responsible Party

**Investigator Affiliation:** Asan Medical Center

**Investigator Full Name:** Jae Yong Jeon, MD

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** Study subjects:

* Patients aged 20 or older who were first diagnosed with breast cancer
* BMI over 23
* 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.

### Conditions Module

**Conditions:**

- Breast Neoplasms

**Keywords:**

- Preoperative Exercise

- Lymphedema

- Breast Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** * Intervention group
* Control group

##### Masking Info

**Masking:** SINGLE

**Masking Description:** * Patients aged 20 or older and younger than 80 years old who were first diagnosed with breast cancer
* BMI of 23 or higher
* Patients scheduled to undergo neoadjuvant chemotherapy before surgery

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Aerobic exercise, Strength training, Flexibility exercise

**Label:** Intervention group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention group

**Description:** 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

**Name:** Aerobic exercise, Strength training, Flexibility exercise

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Bilateral upper limb volume

**Time Frame:** Immediately, Preoperatively, 1 month, 3 months, 6 months.

**Description:** 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.

**Measure:** ICG lymphography

**Time Frame:** Immediately, 6 months.

#### Secondary Outcomes

**Description:** 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.

**Measure:** Body composition

**Time Frame:** Immediately, 6 months.

**Description:** Measurements are made according to a standardized protocol using a goniometer.

**Measure:** Shoulder range of motion

**Time Frame:** Immediately, Preoperatively, 1 month, 3 months, 6 months.

**Description:** 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

**Measure:** Upper limb strength, grip strength

**Time Frame:** Immediately, 6 months

**Description:** Evaluate the patient's quality of life through the corresponding questionnaire

**Measure:** EORTC QLQ-C30

**Time Frame:** Immediately, 6 months

**Description:** Evaluate the patient's quality of life through the corresponding questionnaire

**Measure:** EORTC QLQ-BR23

**Time Frame:** Immediately, 6 months

### Eligibility Module

**Eligibility Criteria:** 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
* Patients with body mass index (BMI) of 23 or more

Exclusion Criteria:

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

**Maximum Age:** 80 Years

**Minimum Age:** 20 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jyjeon71@gmail.com

**Name:** Jaeyong Jeon

**Phone:** +82-2-3010-3791

**Role:** CONTACT

**Contact 2:**

**Email:** miracleofs@naver.com

**Name:** Seungwoo Cha

**Phone:** +82-2-3010-3799

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Asan Medical Center

**Name:** Jaeyong Jeon

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Asan Medical Center

**Name:** Heejeong Kim

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** Asan Medical Center

**Name:** Seungwoo Cha

**Role:** STUDY_CHAIR

**Official 4:**

**Affiliation:** Asan Medical Center

**Name:** Chul Jung

**Role:** STUDY_CHAIR

**Official 5:**

**Affiliation:** Asan Medical Center

**Name:** Hwayeong Cheon

**Role:** STUDY_CHAIR

**Official 6:**

**Affiliation:** Asan Medical Center

**Name:** Junghwa Do

**Role:** STUDY_CHAIR

**Official 7:**

**Affiliation:** Asan Medical Center

**Name:** Woojin Jeong

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000008206

- Term: Lymphatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M11206

- Name: Lymphedema

- Relevance: HIGH

- As Found: Lymphedema

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Neoplasms

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000008209

- Term: Lymphedema

### Misc Info Module

- Version Holder: 2024-05-31
