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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in C-reactive protein (CRP) level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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:
- •incomplete follow up
- •Unwillingness to undergo repeated blood sampling during the study period.
研究组 & 干预措施
Arm 1 : Preoperative shoulder exercise
Arm 1: Preoperative Shoulder Exercise Participants will receive a structured preoperative shoulder range-of-motion exercise program prior to modified radical mastectomy, in addition to standard preoperative care.
干预措施: Preoperative shoulder exercise (Behavioral)
Arm 2 : Standard Preoperative Care
Arm 2: Standard Preoperative Care Participants will receive standard preoperative care without a structured shoulder exercise program prior to modified radical mastectomy.
干预措施: Standard preoperative care (Other)
结局指标
主要结局
Change in C-reactive protein (CRP) level
时间窗: Baseline (preoperative), 1 day before surgery and 1 month after surgery
C-reactive protein (CRP) levels will be measured to assess the postoperative inflammatory response in patients undergoing modified radical mastectomy.
次要结局
- Short Form-36 (SF-36) quality-of-life score(Baseline(before intervention), 1-day preoperative and 1 month after surgery)
研究者
Freda Susana Halim
Surgical Oncology Trainee
Fakultas Kedokteran Universitas Indonesia