Feasibility of Omega-3 Supplementation for Cancer-related Fatigue

描述(申请人提供)：30-80%的乳腺癌幸存者在治疗后10年内报告癌症相关性疲劳(CRF)。慢性肾功能衰竭会降低幸存者参与休闲活动的能力、破坏有意义的关系的能力、工作能力以及参与社交和其他活动的能力，从而对生活质量(QOL)产生负面影响。尽管慢性肾功能衰竭的发病率很高，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，而行为干预显示了疗效，但依从性较差。营养补充干预治疗癌症幸存者的CRF将是理想的，因为实施容易，副作用发生率低。海洋ω-3多不饱和脂肪酸(多不饱和脂肪酸)，一种流行的营养补充剂，可能会降低慢性肾衰。来自对乳腺癌幸存者的前瞻性观察研究和对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慢性肾衰。然而，这些临床试验的主要目的并不是确定补充ω-3对慢性肾功能衰竭的影响，也不是在报告慢性肾衰的乳腺癌幸存者身上进行的。为了检验海洋ω-3对乳腺癌幸存者的影响，有必要1)收集关于它们对慢性肾衰疗效的初步统计数据，2)确定依从性和不良事件，3)收集关于可能的作用机制的初步统计数据，以便为未来试验的设计提供信息。这项拟议的随机试点试验基于生物学上的合理性和初步数据，是一项三臂研究，对两种海洋ω-3补充方案(1.7g/天和3.4g/天)与安慰剂进行了比较。60名乳腺癌幸存者报告了慢性肾功能衰竭(自我报告的慢性肾功能衰竭e4水平，满分为0-10)。拟议的临床试验旨在：1)收集初步统计数据(均值变化和标准 偏差)两种ω-3补充方案与安慰剂相比减少CRF，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 (平均变化和标准差)两种ω-3补充方案与安慰剂的比较 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，与安慰剂相比，补充海洋ω-3对疲惫的乳腺癌幸存者的慢性肾功能衰竭有积极的影响，并将有助于准确计算未来试验的统计力量。这项试验将是首批使用海洋ω-3的临床试验之一。 为报告CRF的乳腺癌幸存者提供补充，旨在提供关键的初步数据，为预期的R01提案提供参考。R01研究将是一项盲法、安慰剂对照的多中心随机对照试验，通过罗切斯特大学癌症中心社区临床肿瘤学计划(URCC CCOP)进行，考察海洋ω-3补充剂对乳腺癌幸存者慢性肾功能衰竭的影响。

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).