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

• 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
• 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; 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

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，由于富含蛋白质的间质液的积累而导致上肢的肿胀，显着影响患者治疗乳腺癌后这种并发症的患者生活质量。据报道，淋巴水肿的发病率是广泛的变化，大多数专家承认的发病率约为25％，在治疗后的任何时间发作。随着乳腺癌的生存继续改善，解决治疗的并发症及其对生活质量的影响需要强大的基于证据的干预措施。当前，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，该数据遭受了缺乏足够尺寸的样本和方法论挑战，尤其是短期随访的情况。干预措施通常需要进入经过特殊培训的治疗师，并要求患者及其护理人员的大量时间和灵巧性，导致进一步的疾病负担和生活质量降低。拟议的试验将尝试通过一种新的方法来解决淋巴水肿，以早期鉴定为轻度临床前淋巴水肿。该样本将包括筛查所有被诊断出患有乳腺癌的新患者，每年平均1000个新的乳腺癌诊断。在治疗乳腺癌调查后，所有新患者都将被要求使用均衡计测量和完成马萨诸塞州综合医院上肢障碍的淋巴水肿筛查。该测量计被认为是手臂体积测量中的“金标准”，并且准确在1％以内。将在基线（在任何手术干预之前），每次治疗之前和之后以及每年至少两次在5年之前和之后进行手臂体积测量。所有患者将在明确的乳房手术后接受标准的护理治疗，包括淋巴水肿的患者教育表和锻炼以恢复肩部运动。我们假设，如果早日检测到淋巴水肿（在患者两臂之间的5-10％体积差异时），早期治疗将防止进展并改善生活质量。在观察疗法和压缩疗法之间随机分配了5-10％的轻度淋巴水肿的受试者8周（n = 208分）。中度淋巴水肿的受试者体积差异为11-20％，将随机分配给有或没有夜间压缩包裹的压缩套筒治疗（n = 128 pts）。该试验的信息应产生数据，以使淋巴水肿的自然史，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。