Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Gary Morrow
- 入组人数
- 108
- 试验地点
- 12
- 主要终点
- Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value
研究概览
简要总结
This randomized pilot clinical trial studies omega-3 fatty acid in reducing cancer-related fatigue in breast cancer survivors. Supplementation with omega-3 fatty acid may help reduce cancer-related fatigue in breast cancer survivors.
详细描述
PRIMARY OBJECTIVE:
I. To collect preliminary statistical data (mean changes and standard deviations) on two omega-3 supplementation (omega-3 fatty acid) regimens (1.65 g/day and 3.3 g/day) compared to placebo for reducing cancer-related fatigue (CRF) in fatigued breast cancer survivors.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive low-dose omega-3 fatty acid supplementation orally (PO) twice daily (BID) and placebo PO BID for 6 weeks.
ARM II: Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed diagnosis of breast cancer; participants can have had more than one primary cancer diagnosis in the past
- •Have undergone some type or combination of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer
- •Have completed all forms of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer between 4 and 36 months prior to enrollment in the study; participants can be currently taking hormones (such as tamoxifen) or monoclonal antibodies (such as Herceptin)
- •Must have cancer-related fatigue, as indicated by a response of 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0" = no fatigue and "10" = as bad as you can imagine
- •Be able to read English
- •Able to swallow medication
- •Give written informed consent
排除标准
- •Have used marine omega-3 supplements at any time within previous 3 months (this includes prescription omega-3 drugs such as Lovaza®)
- •Be taking anticoagulant medication (does not include aspirin)
- •Have sensitivity or allergy to fish and/or shellfish
- •Have sensitivity or allergy to soy and/or soybeans
- •Have confirmed diagnosis of chronic fatigue syndrome or other diagnosis known to cause severe fatigue
研究组 & 干预措施
Arm I (low-dose omega-3 fatty acid)
Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
干预措施: Placebo (Other)
Arm I (low-dose omega-3 fatty acid)
Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
干预措施: Omega-3 Fatty Acid (Dietary Supplement)
Arm I (low-dose omega-3 fatty acid)
Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
干预措施: Questionnaire Administration (Other)
Arm I (low-dose omega-3 fatty acid)
Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (high-dose omega-3 fatty acid)
Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
干预措施: Omega-3 Fatty Acid (Dietary Supplement)
Arm II (high-dose omega-3 fatty acid)
Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
干预措施: Questionnaire Administration (Other)
Arm II (high-dose omega-3 fatty acid)
Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
Arm III (placebo)
Patients receive placebo PO BID for 6 weeks.
干预措施: Placebo (Other)
Arm III (placebo)
Patients receive placebo PO BID for 6 weeks.
干预措施: Questionnaire Administration (Other)
Arm III (placebo)
Patients receive placebo PO BID for 6 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value
时间窗: Baseline to 6 weeks
BFI-SF is a 4 item questionnaire to assess the severity of fatigue, ranging from 0 (No Fatigue) to 10 (As bad as you can imagine). MFSI-SF is a 30 item questionnaire to assess the level of fatigue in terms of general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor). First four subscales (general, physical, emotional, and mental) are summed and the vigor scale is subtracted to create fatigue total score with a range of -32 (low fatigue) to 96 (high fatigue).
次要结局
未报告次要终点
研究者
Gary Morrow
Principal Investigator, URCC NCORP Research Base
University of Rochester NCORP Research Base