The Second Clinical College of Wuhan University, Wuhan, Hubei, China.
Department of Rehabilitation Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.
Trials. 2021 Jan 6;22(1):16. doi: 10.1186/s13063-020-04954-3.
Due to advancements in treatment, the survival of breast cancer (BC) patients has significantly improved. Improving the postoperative quality of life has become a widespread concern for patients and doctors. At present, the staged rehabilitation training program for postoperative BC patients has been recognized. However, there is not yet a consensus about the optimal time to initiate rehabilitation training. We designed this study to investigate the optimal intervention times for postoperative BC patients to begin different stages of rehabilitation.
This is a randomized controlled trial. Female participants with BC who are scheduled to undergo mastectomy, including unilateral total breast or breast-conserving surgery plus axillary lymph node dissection, will be enrolled in this study. The intervention includes the following: 200 participants will be allocated using a 1:1:1:1 ratio to the A, B, C, and D groups, which have four different rehabilitation timelines for four phases of rehabilitation exercises. A therapist will evaluate the patient's overall health and then adjust the training intensity before initiating training. The assessments include upper limb mobility, grip, limb circumference, postoperative drainage volume (PDV), and pain. The training will last for 12 weeks, and patients will undergo follow-up twice within 6 weeks after discharge. Outcomes include the following: Constant-Murley Score (CMS) is the primary parameter. European Organization Research and Treatment of Cancer Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23), SF-36, range of motion (ROM), strength, grip, circumference, PDV, and pain are the secondary parameters. All enrolled subjects will be assessed at 1 day, 3 days, 1 week, and 2, 3, 6, 9, 12, and 18 weeks after the surgery.
This is a randomized controlled trial to evaluate the effect of different rehabilitation training timelines to prevent shoulder dysfunction among postoperative patients with BC. If the results are confirmed, this study will establish an optimal timeline for postoperative BC rehabilitation.
ClinicalTrials.gov NCT03658265 . Registered on September 2018.
由于治疗手段的进步，乳腺癌（BC）患者的生存率有了显著提高。提高术后生活质量成为患者和医生共同关注的问题。目前，乳腺癌患者术后分阶段康复训练方案已得到认可，但对于开始康复训练的最佳时间尚未达成共识。我们设计本研究旨在探讨乳腺癌患者开始不同阶段康复的最佳干预时间。
这是一项随机对照试验。将招募计划接受乳腺癌改良根治术的女性患者，包括单侧全乳或保乳手术加腋窝淋巴结清扫术，将其纳入本研究。干预措施包括：采用 1:1:1:1 比例将 200 名参与者分配到 A、B、C 和 D 组，这 4 组有 4 种不同的康复时间表，适用于康复运动的 4 个阶段。治疗师将在开始训练前评估患者的整体健康状况，并调整训练强度。评估包括上肢活动度、握力、肢体周长、术后引流量（PDV）和疼痛。训练将持续 12 周，患者将在出院后 6 周内进行 2 次随访。主要结局包括：Constant-Murley 评分（CMS）。次要结局包括欧洲癌症研究与治疗组织生活质量问卷-BR23（EORTC QLQ-BR23）、SF-36、活动度、力量、握力、周长、PDV 和疼痛。所有入组患者将在术后 1 天、3 天、1 周以及 2、3、6、9、12 和 18 周进行评估。
本研究旨在评估不同康复训练时间方案对预防乳腺癌术后患者肩功能障碍的效果。如果结果得到证实，本研究将为乳腺癌术后康复制定最佳时间表。
ClinicalTrials.gov NCT03658265。于 2018 年 9 月注册。
