A Pilot Feasibility Trial of the Tolerability of Oral Salvia Hispanica and Its Effect on Blood Fatty Acids and Stool Microbiome in Patients With Treated Non-Hodgkin Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Changes in improvement of n-3 serum alpha-linoleic acid levels
研究概览
简要总结
This pilot clinical trial studies Salvia hispanica seed in reducing the risk of returning disease (recurrence) in patients with non-Hodgkin lymphoma. Functional foods, such as Salvia hispanica seed, has health benefits beyond basic nutrition by reducing disease risk and promoting optimal health. Salvia hispanica seed contains essential poly-unsaturated fatty acids, including omega 3 alpha linoleic acid and omega 6 linoleic acid; it also contains high levels of antioxidants and dietary soluble fiber. Salvia hispanica seed may raise omega-3 levels in the blood and/or change the bacterial populations that live in the digestive system and reduce the risk of disease recurrence in patients with non-Hodgkin lymphoma.
详细描述
PRIMARY OBJECTIVES:
I. Assess if dietary supplementation with the functional food Salvia hispanica (SH) seed improves serum omega-3 (n-3) fatty acids (FA) levels in patients with non-Hodgkin lymphoma (NHL) who have recently completed chemotherapy.
SECONDARY OBJECTIVES:
I. Evaluate the safety and tolerability of patients taking 16 grams (g) (approximately 1 United States [US] tablespoon) of SH per day.
II. Evaluate the compliance of stool sample collection in lymphoma patients who have completed therapy and are in remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Have a diagnosis of any type of NHL and =< 5 years from the last treatment
- •In remission (complete remission [CR], partial remission [PR], or stable disease based on clinical, not necessarily radiologic, assessment) and currently being observed and with no current cytotoxic chemotherapy planned; patients may be on rituximab maintenance
- •No international travel planned during the next 4 months
- •Able to eat a full range of solid food and liquids and tolerate seeds/nuts
- •Maintain a consistent general diet without significant variation
- •Able to deliver four fresh (within 24 hours) stool samples to Mayo Clinic Rochester over a four month period
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- •Provide informed written consent
- •Able to recollect dietary intake for the prior 24 hours in order to complete a one-day food record with assistance from a dietician at each study visit
- •Willing to complete the food frequency questionnaire (FFQ) at baseline and at 16 week visits with assistance from a dietician
- •Willing to be seen at baseline, 6 weeks, 12 weeks, and 16 weeks for the study time points
- •Willing to provide blood and stool samples at baseline and study time points for correlative research purposes
排除标准
- •Cannot eat normal table food by mouth; NOTE: patients with any form of feeding tube or a swallowing disorder are not eligible
- •Have taken fish oil, another dedicated n-3 supplement, or SH seed from another source within the last 28 days; patients on multivitamins that contain n-3 are eligible
- •Co-morbid systemic illnesses such as active infection or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens; NOTE: patients with significant gut malabsorptive conditions (such as inflammatory bowel disease or others at the discretion of the investigator) will be excluded
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Receiving any other investigational agent that would be considered as a treatment for the lymphoma; NOTE: rituximab maintenance and patients participating on Mayo Clinic vitamin D study are allowed
- •Active other malignancy requiring treatment that would interfere with the assessments of this study
- •Major surgery other than diagnostic surgery =< 4 weeks prior to registration
- •On prophylactic antibiotics, such as trimethoprim-sulfamethoxazole for pneumocystis prophylaxis or post-transplant penicillin prophylaxis
- •Have taken antibiotics =< 7 days prior to registration
结局指标
主要结局
Changes in improvement of n-3 serum alpha-linoleic acid levels
时间窗: Baseline to up to 16 weeks
n-3 level will be evaluated as a continuous measure, where the median and range will be summarized at each time point. Changes across time will be evaluated graphically. Changes from baseline will be quantitatively summarized and will be evaluated using paired sample methods (paired sample t-test).
次要结局
- Changes in n-3 levels after participants are no longer taking SH(From 12 weeks to up to 16 weeks)
- Changes in stool microbiome after supplementation with SH, assessed by gene sequencing(Baseline to up to 16 weeks)
- Patient compliance in stool sample collection(Up to 16 weeks)
- Changes in stool microbiome after participants are no longer taking SH(From 12 weeks to up to 16 weeks)
- Incidence of adverse events graded according to the National Cancer Institute Common Toxicity Criteria version 4.0(Up to 16 weeks)