Dietary Intervention in Stage III/IV Follicular Lymphoma. Impact on Markers of Cell Proliferation, Apoptosis, Host Immune Cell Infiltrate and Oxidative Stress.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Apoptosis an proliferation rate in tumor cells,
研究概览
简要总结
A dietary intervention study in patients with Follicular Lymphoma (FL) Stage III/IV to assess the ability of several dietary factors to induce apoptosis, inhibit cell proliferation and modulate tumor cell infiltrate in vivo.
详细描述
Dietary factors plays an important role in the prevention of several diseases. The cardiovascular disease mortality have dropped dramatically the last 20 years, but the relative death rates from cancer remains fairly stable. There is reason to believe that factors in the tumors microenvironment is of great importance for the outcome of many malignant diseases, including FL. Factors predicting a poor outcome are associated with inflammation, oxidative stress which both impair the hosts immune response and produces growth stimulatory signals. In this open study with 45 patients to be included we seek to perform a dietary intervention with comparison of apoptosis rate, proliferation rate and immune cell infiltrate before and after the intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age 18 years or more.
- •Permanent address in Norway, located in health region south or east. People living outside these areas in other health regions in Norway may be able to participate but after individual evaluation.
- •Histologically verified follicular lymphoma grade I or II without clinical signs of transformation to aggressive lymphoma.
- •Stage III/IV.
- •Previously untreated or at least 1 year since rituximab treatment or 6 months since cytotoxic chemotherapy.
- •Not scheduled for disease specific treatment for the next 3 months.
- •At least one pathological superficial lymph node available for ultrasound guided biopsy.
- •Cytologically and/or immunocytologically compatible with follicular lymphoma.
- •Women with childbearing potential, only with use of safe contraceptives
排除标准
- •Gross abnormalities in blood samples. (Hematologic values Hgb< 10, leukocytes< 2,5, trombocytes <100, liver enzymes (ALAT,ASAT,GT,ALP) > 2,5 x upper normal values,bilirubin >35 creatinine >130)
- •Other serious medical illness (unstable cardiovascular disease, unstable pulmonary disease, uncontrolled diabetes, autoimmunity, chronic infection or other active cancer).
- •Use of NSAID, ASA the last two weeks prior to enrollment.
- •Use of systemic corticosteroids the last two months prior to enrollment.
- •Regular use of anticoagulants as LMW Heparin or warfarin.
- •Use of carbamazepin, nifedipin and other drugs metabolized with CYP 3A4 where interaction might cause hazardous side effects which cannot be controlled with serum measurements or organ function monitoring.
- •Inclusion in another clinical trial which involves medication or nutritional supplements.
- •Use of complementary medicine/alternative medicine which includes high dose* vitamins or antioxidants/nutritional supplements 2 weeks prior to sampling procedures .
- •Regularly use of omega 3 fatty acids more than 1g / day
- •History of serious or unstable medical or psychiatric disorder.
- •History of heavy alcohol consumption > 3 units / day.
- •Pregnancy
- •Individuals judged by the clinical investigator to be unable to follow instructions and procedures of the study.
- •(*high dose is defined as vitamins or antioxidant supplements exceeding what is present in regular multi-vitamin supplements covering regular RDAs)
结局指标
主要结局
Apoptosis an proliferation rate in tumor cells,
时间窗: At the end of intervention (week 16)
次要结局
- Levels of: proinflammatory cytokines,tumor immune cell infiltrate(Week 16)