Набор скоро начнётся NCT07420335

Preoperative Shoulder Exercises and Postoperative Inflammation, Pain, and Function After Modified Radical Mastectomy

Без фазы С лечением Locally Advanced Breast Cancer (LABC) Postoperative Inflammation Prehabilitation

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: Preoperative shoulder exercise, Standard preoperative care.
Кому может быть актуально: Состояния в реестре: Locally Advanced Breast Cancer (LABC), Postoperative Inflammation, Prehabilitation. Базовые параметры: 18 лет — 70 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: Индонезия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effect of Preoperative Shoulder Range-of-Motion Exercises on C-Reactive Protein (CRP) Levels, Pain, and Shoulder Joint Dysfunction, as Well as Quality of Life in Patients With Locally Advanced Breast Cancer After Modified Radical Mastectomy

Обзор

This study evaluates whether preoperative shoulder range-of-motion exercises influence postoperative inflammatory response, pain, shoulder function, and quality of life in patients with locally advanced breast cancer undergoing modified radical mastectomy.

Подробное описание

Breast cancer patients undergoing modified radical mastectomy are at risk of postoperative pain, shoulder dysfunction, and impaired quality of life, which may be associated with postoperative inflammatory responses. Preoperative rehabilitation strategies, including shoulder range-of-motion exercises, have been proposed to improve postoperative recovery, but evidence in patients with locally advanced breast cancer remains limited.

This study aims to evaluate the effects of a structured preoperative shoulder range-of-motion exercise program on postoperative inflammatory markers, specifically C-reactive protein (CRP), as well as pain intensity, shoulder joint function, and quality of life in patients with locally advanced breast cancer undergoing modified radical mastectomy.

Вмешательства

Поведенческое Preoperative shoulder exercise
Arm 1 : Participants in the intervention arm will perform a structured preoperative shoulder range-of-motion exercise program prior to modified radical mastectomy. The exercises are designed to maintain shoulder mobility and are conducted in addition to standard preoperative care.
Другое Standard preoperative care
Participants will receive standard preoperative care without a structured shoulder exercise program prior to modified radical mastectomy.

Первичные конечные точки

Change in C-reactive protein (CRP) level [Срок оценки: Baseline (preoperative), 1 day before surgery and 1 month after surgery]

Вторичные конечные точки (1)

Short Form-36 (SF-36) quality-of-life score [Срок оценки: Baseline(before intervention), 1-day preoperative and 1 month after surgery]

Критерии участия

Критерии включения

Patients with clinically locally advanced breast cancer (stage IIIA-IIIC according to the American Joint Committee on Cancer staging system) who have been scheduled to undergo modified radical mastectomy.
Age ≥ 18 years at the time of diagnosis
Willing to undergo preoperative rehabilitation for 6-8 weeks and to perform the recommended home-based exercise program.
Willing to participate in follow-up via telephone.

Критерии исключения

Inability to understand verbal or written communication, resulting in difficulty following exercise instructions.
Intraoperative complications, such as injury to or transection of the thoracodorsal nerve, long thoracic nerve, and/or intercostobrachial nerve.
Postoperative complications leading to delayed wound healing, defined as incomplete wound healing at one month after surgery, including wound dehiscence, wound infection, or abscess formation.
Pre-existing shoulder joint motion limitation diagnosed prior to surgery (e.g., preoperative frozen shoulder).
Presence of inflammatory conditions in other body regions at the start of or during the study that may result in elevated leukocyte counts, such as diarrhea, urinary tract infection, or skin infection.
Requirement for nonsteroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids for the management of inflammation.

Drop out criteria: