Early Detection and Treatment of Lymphedema in Women with Breast Cancer

乳腺癌女性淋巴水肿的早期发现和治疗

基本信息

批准号：
8444319
负责人：
ALPHONSE G TAGHIAN
金额：
$ 25.47万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-04-01 至 2014-05-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8444319
关键词：
Address Aftercare Age Air Articular Range of Motion Breast Cancer Treatment Caregivers Chest Clinical Trials Comorbidity Complex Complication Comprehensive Cancer Center Compression Bandage Data Diagnosis Distress Early Diagnosis Early Intervention Early identification Early treatment Evidence based intervention Exercise Fright General Hospitals Gold Hand Health Impairment Incidence Intercellular Fluid Intervention Lymphedema Massachusetts Measurement Methods Motion Natural History Occupations Operative Surgical Procedures Patient Education Patients Prevention Proteins Quality of life Randomized Regimen Reporting Risk Factors Sample Size Sampling Shoulder Surveys Swelling Symptoms Testing Time Training Travel Upper Extremity Woman arm avoidance behavior base breast cancer diagnosis breast surgery burden of illness experience follow-up functional disability improved malignant breast neoplasm novel strategies pre-clinical prevent screening standard of care treatment adherence

项目摘要

DESCRIPTION (provided by applicant): Lymphedema, a swelling of the upper extremity due to an accumulation of protein rich interstitial fluid, significantly impacts the quality of life of patients who develop this complication following their treatment for breast cancer. Lymphedema incidence is reported to be widely variable with most experts conceding an incidence rate of approximately 25 percent, with onset occurring at any time post treatment. As survival from breast cancer continues to improve, addressing complications of treatment and its ensuing impact on quality of life necessitate strong evidence based interventions. Currently, the treatment of lymphedema has been largely based on clinician experience and a growing body of clinical trial data that suffers from lack of adequately sized samples and methodological challenges, particularly short-term follow-up. Interventions often require access to specially trained therapists and demand considerable time and dexterity from patients and their caregivers resulting in further illness burden and diminished quality of life. The proposed trial will attempt to address lymphedema with a novel approach based on early identification of mild, pre-clinical lymphedema. The sample will include screening of all new patients diagnosed with breast cancer in a large urban comprehensive cancer center averaging 1000 new breast cancer diagnoses per year. All new patients will be asked to participate in lymphedema screening using Perometer measurements and completion of the Massachusetts General Hospital Upper Extremity Impairments Following Treatment for Breast Cancer Survey. The Perometer is considered the "gold standard" in arm volume measurement, and is accurate within 1 percent. Arm volume measurements will be obtained at baseline (prior to any surgical intervention), before and after each treatment and at least twice per year for 5 years. All patients will receive standard of care treatment following definitive breast surgery including the Lymphedema Patient Education Sheet and exercises for regaining shoulder motion post operatively. We hypothesize that if lymphedema is detected early enough (at the onset of 5-10 percent volume difference between the patients two arms), early treatment will prevent progression and improve quality of life. Subjects who develop mild lymphedema of 5-10 percent will be randomized between observation and compression therapy for 8 weeks (n=208 pts). Subjects with moderate lymphedema of 11-20 percent volume difference will be randomized to compression sleeve therapy with and without night time compression wrapping (n=128 pts). Information from this trial should yield data that will bring clarity to the natural history of lymphedema, efficacy of early intervention, and the impact of lymphedema on functional impairment and quality of life.

描述（由申请人提供）：淋巴水肿是由于富含蛋白质的间质液积聚而导致的上肢肿胀，显着影响乳腺癌治疗后出现这种并发症的患者的生活质量。据报道，淋巴水肿的发病率差异很大，大多数专家承认其发病率约为 25%，且在治疗后的任何时间都会发病。随着乳腺癌生存率不断提高，解决治疗并发症及其对生活质量的影响需要采取强有力的基于证据的干预措施。目前，淋巴水肿的治疗主要基于临床医生的经验和越来越多的临床试验数据，但缺乏足够大小的样本和方法学挑战，特别是短期随访。干预措施通常需要接受专门培训的治疗师，并需要患者及其护理人员投入大量时间和技巧，从而导致进一步的疾病负担和生活质量下降。拟议的试验将尝试通过一种基于早期识别轻度临床前淋巴水肿的新方法来解决淋巴水肿。该样本将包括对大型城市综合癌症中心的所有新诊断乳腺癌患者进行筛查，平均每年诊断出 1000 例新乳腺癌患者。所有新患者都将被要求参加使用 Perometer 测量的淋巴水肿筛查，并完成马萨诸塞州总医院乳腺癌治疗后上肢损伤调查。 Perometer 被认为是手臂体积测量的“黄金标准”，准确度在 1% 以内。将在基线（任何手术干预之前）、每次治疗之前和之后进行手臂体积测量，并且每年至少测量两次，持续 5 年。所有患者在确定性乳房手术后都将接受标准护理治疗，包括淋巴水肿患者教育表和术后恢复肩部运动的练习。我们假设，如果足够早地发现淋巴水肿（在患者两臂之间体积差异为 5-10% 时），早期治疗将防止进展并改善生活质量。出现 5-10% 轻度淋巴水肿的受试者将被随机分配接受为期 8 周的观察治疗和加压治疗（n=208 名患者）。体积差异为 11-20% 的中度淋巴水肿受试者将被随机分配接受带或不带夜间压缩包裹的压缩袖套疗法（n=128 名患者）。该试验的信息应该产生数据，这些数据将澄清淋巴水肿的自然史、早期干预的功效以及淋巴水肿对功能障碍和生活质量的影响。

项目成果

期刊论文数量（22）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Weight loss does not decrease risk of breast cancer-related arm lymphedema.

DOI：
10.1002/cncr.33819
发表时间：
2021-11-01
期刊：
Cancer
影响因子：
6.2
作者：
Roberts SA;Gillespie TC;Shui AM;Brunelle CL;Daniell KM;Locascio JJ;Naoum GE;Taghian AG
通讯作者：
Taghian AG

Methods for quantifying breast cancer-related lymphedema in patients undergoing a contralateral prophylactic mastectomy.

量化接受对侧预防性乳房切除术的患者中乳腺癌相关淋巴水肿的方法。