Clinical trial NCT06421285: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Keywords: Preoperative Exercise
Lymphedema
Breast Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Intervention group
* Control group
Primary purpose: SUPPORTIVE_CARE

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
* 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.

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

Exclusion Criteria:

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

Primary outcomes:
measure: Bilateral upper limb volume
timeFrame: Immediately, Preoperatively, 1 month, 3 months, 6 months.
measure: ICG lymphography
timeFrame: Immediately, 1 month, 6 months.
Secondary outcomes:
measure: Body composition
timeFrame: Immediately, 6 months.
measure: Shoulder range of motion
timeFrame: Immediately, Preoperatively, 1 month, 3 months, 6 months.
measure: Upper limb strength, grip strength
timeFrame: Immediately, 6 months
measure: EORTC QLQ-C30
timeFrame: Immediately, 6 months
measure: EORTC QLQ-BR23
timeFrame: Immediately, 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
state: Seoul Special City
Study officials:
affiliation: Asan Medical Center
name: Jaeyong Jeon
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Heejeong Kim
role: STUDY_CHAIR
affiliation: Asan Medical Center
name: Seungwoo Cha
role: STUDY_CHAIR
affiliation: Asan Medical Center
name: Chul Jung
role: STUDY_CHAIR
affiliation: Asan Medical Center
name: Hwayeong Cheon
role: STUDY_CHAIR
affiliation: Asan Medical Center
name: Junghwa Do
role: STUDY_CHAIR
affiliation: Asan Medical Center
name: Woojin Jeong
role: STUDY_CHAIR
affiliation: Asan Medical Center
name: Doyoung Kim
role: STUDY_CHAIR
References: