Идёт набор NCT06421285

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

Без фазы С лечением Breast Neoplasms

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Aerobic exercise, Strength training, Flexibility exercise.
Кому может быть актуально: Состояния в реестре: Breast Neoplasms. Базовые параметры: 20 лет — 80 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: South Korea
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое 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:

Первичные конечные точки

Bilateral upper limb volume [Срок оценки: Immediately, Preoperatively, 1 month, 3 months, 6 months.]
ICG lymphography [Срок оценки: Immediately, 1 month, 6 months.]

Вторичные конечные точки (5)

Body composition [Срок оценки: Immediately, 6 months.]
Shoulder range of motion [Срок оценки: Immediately, Preoperatively, 1 month, 3 months, 6 months.]
Upper limb strength, grip strength [Срок оценки: Immediately, 6 months]
EORTC QLQ-C30 [Срок оценки: Immediately, 6 months]
EORTC QLQ-BR23 [Срок оценки: Immediately, 6 months]

Критерии участия

Критерии включения

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