Feasibility of Omega-3 Supplementation for Cancer-related Fatigue

描述（由申请人提供）：治疗后10年内，30-80%的乳腺癌幸存者报告了癌症相关疲劳（CRF）。CRF可通过降低幸存者参与休闲活动的能力、维持有意义关系的能力、工作能力以及参与社交及其他活动的能力，对生活质量（QOL）产生负面影响。尽管CRF的高患病率及其负面后果，但治疗选择有限。药物治疗的疗效和副作用有限，而行为干预已证明有效，但依从性差。营养补充干预治疗癌症幸存者的CRF将是理想的，由于易于实施和低发生率的副作用。 海洋ω-3多不饱和脂肪酸（PUFA）是一种流行的营养补充剂，可降低CRF。来自乳腺癌幸存者的前瞻性观察性研究和晚期癌症患者的小型临床试验的有希望的初步证据表明，海洋ω-3补充剂可能通过减少炎症反应来减少CRF。然而，这些临床试验的主要目的不是确定ω-3补充剂对CRF的影响，并且它们不是在报告CRF的乳腺癌幸存者中进行的。为了检查海洋ω-3补充剂对乳腺癌幸存者的影响，必须1）收集有关其对CRF影响的初步统计数据，2）确定依从性和不良事件，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。基于生物相容性和初步数据，拟议的随机化初步试验是一项三臂研究，在60名报告CRF的乳腺癌幸存者中比较两种海洋ω-3补充方案（1.7 g/天和3.4 g/天）与安慰剂（自我报告CRF水平e4，0-10分）。拟定的临床试验旨在：1）收集初步统计数据（平均变化和标准 2）确定两种ω-3补充方案与安慰剂相比的依从性和不良事件，以及3）收集初步统计数据 (mean变化和标准差）与安慰剂相比 用于减少乳腺癌幸存者的炎症。我们假设，初步统计数据将显示，与安慰剂相比，海洋ω-3补充剂对疲劳乳腺癌幸存者的CRF有积极影响，并将有助于准确计算未来试验的统计功效。这项试验将代表第一个临床试验之一，管理海洋ω-3 是对报告CRF的乳腺癌幸存者的补充，旨在提供关键的初步数据，为预期的R 01提案提供信息。R 01研究将是一项设盲、安慰剂对照、多中心RCT，通过罗切斯特大学癌症中心社区临床肿瘤学项目（URCC CCOP）在乳腺癌幸存者中检查海洋ω-3补充剂对CRF的影响。

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 ω-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 ω-3 supplementation reduces CRF, possibly by reducing inflammatory responses. The primary aims of those clinical trials, however, were not to determine the effect of ω-3 supplementation on CRF, and they were not conducted in breast cancer survivors reporting CRF. To examine the effect of marine ω-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 ω-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 ω-3 supplementation regimens compared to placebo for reducing CRF, 2) determine the adherence and adverse events for the two ω-3 supplementation regimens compared to placebo, and 3) collect preliminary statistical data (mean changes and standard deviations) on two ω-3 supplementation regimens compared to placebo for reducing inflammation in breast cancer survivors. We hypothesize that preliminary statistical data will show marine ω-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 ω-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 ω-3 supplementation on CRF in breast cancer survivors conducted through the University of Rochester Cancer Center Community Clinical Oncology Program (URCC CCOP).