Feasibility of Omega-3 Supplementation for Cancer-related Fatigue

补充 Omega-3 治疗癌症相关疲劳的可行性

• 批准号: 8637297
• 负责人: Luke Joseph Peppone
• 金额: $ 7.68万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-03-05 至 2016-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8637297
• 关键词: Adherence; Adjuvant; Advanced Malignant Neoplasm; Adverse effects; Adverse event; Aftercare; Behavior Therapy; Biological; Blinded; Cancer Center; Cancer Patient; Cancer Survivor; Clinical; Clinical Trials; Clinical Trials Design; Cohort Studies; Collection; Community Clinical Oncology Program; Data; Disseminated Malignant Neoplasm; Distress; Dose; Exercise; Fatigue; Female Breast Carcinoma; Future; High Prevalence; Incidence; Inflammation; Inflammatory Response; Intake; Interleukin-6; Intervention; Leisure Activities; Malignant Neoplasms; Marines; Nutritional; Observational Study; Omega-3 Fatty Acids; Participant; Patient Self-Report; Patients; Pharmacologic Substance; Pilot Projects; Placebo Control; Placebos; Polyunsaturated Fatty Acids; Population Study; Quality of life; Randomized; Regimen; Reporting; Research; Resources; Safety; Supplementation; Survivors; TNF gene; Time; Treatment-Related Cancer; Universities; Woman; Work; base; design; dietary supplements; effective intervention; innovation; malignant breast neoplasm; pilot trial; prospective; psychologic; public health relevance; social; three-arm study

DESCRIPTION (provided by applicant): Cancer-related fatigue (CRF) is reported by 30-80% of breast cancer survivors up to 10 years post-treatment. CRF can negatively impact quality of life (QOL) by reducing survivors' ability to participate in leisure activities, their capacity to sstain meaningful relationships, their ability to work, and their capacity to engage in social and other activities. Despite the high prevalence of CRF and its negative consequences, treatment options are limited. Pharmaceutical treatments have limited efficacy and side effects, while behavioral interventions have demonstrated efficacy but poor compliance. A nutritional supplementation intervention for the treatment of CRF in cancer survivors would be ideal due to easy implementation and a low incidence of side effects. Marine ?-3 Polyunsaturated Fatty Acids (PUFA), a popular nutritional supplement, may reduce CRF. Promising preliminary evidence from prospective observational studies in breast cancer survivors and small clinical trials in advanced cancer patients show marine ?-3 supplementation reduces CRF, possibly by reducing inflammatory responses. The primary aims of those clinical trials, however, were not to determine the effect of ?-3 supplementation on CRF, and they were not conducted in breast cancer survivors reporting CRF. To examine the effect of marine ?-3 supplementation in breast cancer survivors, it is imperative to 1) collect preliminary statistical data regarding their effec on CRF, 2) determine adherence and adverse events, and 3) collect preliminary statistical data on possible mechanisms of action to inform the design of future trials. The proposed randomized pilot trial, based upon both biological plausibility and preliminary data, is a three-arm study of two marine ?-3 supplementation regimens (1.7 g/day and 3.4 g/day) compared to placebo in 60 breast cancer survivors reporting CRF (self-reported CRF level e4 on a 0-10 scale). The proposed clinical trial aims to: 1) collect preliminary statistical data (mean changes and standard deviations) on two ?-3 supplementation regimens compared to placebo for reducing CRF, 2) determine the adherence and adverse events for the two ?-3 supplementation regimens compared to placebo, and 3) collect preliminary statistical data (mean changes and standard deviations) on two ?-3 supplementation regimens compared to placebo for reducing inflammation in breast cancer survivors. We hypothesize that preliminary statistical data will show marine ?-3 supplementation has a positive effect on CRF compared to placebo in fatigued breast cancer survivors and will help to accurately calculate statistical power for future trials. This trial would represent one of the first clinical trials to administer marine ?-3 supplements to breast cancer survivors reporting CRF and is designed to provide critical preliminary data to inform an anticipated R01 proposal. The R01 study will be a blinded, placebo-controlled, multicenter RCT that examines the effect of marine ?-3 supplementation on CRF in breast cancer survivors conducted through the University of Rochester Cancer Center Community Clinical Oncology Program (URCC CCOP).

描述（由申请人提供）：与癌症相关的疲劳（CRF）报告了30-80％的乳腺癌幸存者在治疗后长达10年。 CRF通过降低幸存者参与休闲活动的能力，有意义的关系，工作能力以及他们从事社交和其他活动的能力，从而对生活质量（QOL）产生负面影响。尽管CRF的患病率很高及其负面后果，但治疗方案仍有限。药物治疗的功效和副作用有限，而行为干预措施表现出疗效，但依从性差。癌症幸存者中CRF治疗的营养补充干预措施将是理想的选择，因为易于实施和副作用的发病率低。 海洋？-3多不饱和脂肪酸（PUFA）是一种流行的营养补充剂，可能会减少CRF。从乳腺癌幸存者中的前瞻性观察研究和晚期癌症患者的小型临床试验中提供的有希望的初步证据显示，补充可以通过减少炎症反应来减少CRF。但是，这些临床试验的主要目的不是确定补充CRF的影响，并且在报告CRF的乳腺癌幸存者中没有进行。为了检查海洋的影响吗？-3补充乳腺癌幸存者，必须1）收集有关其在CRF上的效率的初步统计数据，2）确定依从性和不良事件，以及3）收集有关可能作用机制的初步统计数据，以告知未来试验的设计。根据生物学的合理性和初步数据，提出的随机试验试验是对两种海洋盐的三臂研究？-3补充方案（1.7 g/day和3.4 g/day），与60种乳腺癌幸存者相比，报告了CRF的60种乳腺癌幸存者（自我报销的CRF级E4在0-10尺度上）。拟议的临床试验的目的是：1）收集初步统计数据（平均变化和标准 与安慰剂减少CRF相比，两种补充方案的偏差），2）确定与安慰剂相比，两种补充方案的依从性和不良事件，3）收集初步统计数据 （平均变化和标准偏差）与安慰剂相比，两种补充方案 用于减少乳腺癌幸存者的炎症。我们假设初步的统计数据将显示海洋吗？-3补充对CRF的补充与疲劳乳腺癌幸存者的安慰剂相比具有积极作用，并将有助于准确计算以后试验的统计能力。该试验将代表管理海洋的第一批临床试验之一？-3 为报告CRF的乳腺癌幸存者的补充，旨在提供关键的初步数据，以告知预期的R01提案。 R01研究将是一项盲目的，安慰剂对照的多中心RCT，检查了海洋疾病的影响吗？-3补充对通过罗切斯特癌症中心社区社区临床肿瘤学计划（URCC CCOP）进行的乳腺癌幸存者中CRF的影响。