NCT03831698进行中（未招募）2 期
Omega 3 Fatty Acids in Colorectal Cancer (CRC) Prevention in Patients With Lynch Syndrome (COLYNE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Retention rate of participants
研究概览
简要总结
This is a pilot study aimed at assessing the effects of moderate dose omega-3-acid ethyl esters capsules (generic Lovaza) on molecular, and intestinal microbiota changes in participants at high risk for colorectal cancer. The study will be a single arm, open label study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability of participant or Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- •Candidate for elective endoscopy procedure
- •Participants with known Lynch Syndrome
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •Willing to undergo a colonoscopy and biopsy at baseline and another colonoscopy and biopsy at 12 months visit.
- •Participants taking Aspirin for chemoprevention must agree to stop it for at least 4 weeks prior to study entry and throughout the trial period
- •Adequate organ and marrow function
- •Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Men of child-bearing potential must not father a child or donate sperm while on this study and for 90 days after their last study treatment.
排除标准
- •Current or anticipated use of other investigational agents while participating in this study.
- •Psychiatric illness/social situations that could limit compliance with study requirements.
- •Pregnant or breast feeding.
- •Familial adenomatous polyposis, Putz-Jeghers disease, ulcerative colitis, or Crohn's disease.
- •Previous or known active malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for more than 5 years
- •Current use of anticoagulation therapy
- •Current use of therapeutic doses of aspirin for reasons other than chemoprevention
- •Use of omega 3 fatty acids or flaxseed supplements within 4 weeks before this study's screening/baseline colonoscopy
- •Use of high dose omega 3 fatty acids within the past 3 months prior to study baseline/screening
- •Current, regular use of non-steroidal anti-inflammatory drugs (NSAIDS)
- •Allergy to fish and/or fish products
- •Uncontrolled infectious disease
- •Malabsorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel.
- •Unable to swallow and retain oral medication
研究组 & 干预措施
Omega-3, 2 grams
Experimental
Omega-3 fatty acid ethyl esters (2 grams) orally (by mouth) once per day for 12 months
干预措施: Omega-3 fatty acid ethyl esters (2 gram) (Drug)
结局指标
主要结局
Retention rate of participants
时间窗: 12 months
Feasibility is defined as at least 80% retention rate
次要结局
- Proportion of participants with treatment-related adverse events in each arm.(12 months)
研究者
研究点 (1)
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