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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06421285
• Other study ID #: 2024-0255
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 27, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Asan Medical Center
• Contact: Jaeyong Jeon
• Phone: +82-2-3010-3791
• Email: jyjeon71[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Lymphedema

Intervention

Behavioral:
• Aerobic 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bilateral upper limb volume	Using a tape measure, measure the circumference from the wrist to the armpit every 4cm, then apply the SCircumference2/p formula to calculate the volume of the upper limb.	Immediately, Preoperatively, 1 month, 3 months, 6 months.
Primary	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, 6 months.
Secondary	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.	Immediately, 6 months.
Secondary	Shoulder range of motion	Measurements are made according to a standardized protocol using a goniometer.	Immediately, Preoperatively, 1 month, 3 months, 6 months.
Secondary	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	Immediately, 6 months
Secondary	EORTC QLQ-C30	Evaluate the patient's quality of life through the corresponding questionnaire	Immediately, 6 months
Secondary	EORTC QLQ-BR23	Evaluate the patient's quality of life through the corresponding questionnaire	Immediately, 6 months