Effect of Vegan Diet and Lifestyle Changes on the Course and Progression of Indolent Lymphoma During Controlled Waiting Period
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Partial remission or complete remission
研究概览
简要总结
The aim of the present trial is to evaluate the effect of lifestyle changes on the natural history of indolent lymphomas, during the period of watchful waiting. The intervention program is comprised of specifically designed vegan nutrition, physical activity, mostly aerobic, and stress reduction by relaxation and meditation. Outcome results will be followed and analyzed for 3 years, taking into consideration the following parameters - disease burden, specific disease-related symptoms, relevant blood tests, body weight, indicators of well-being. Changes in these parameters will be correlated with the level of compliance and adherence to the intervention program. The results of the trial group of patients will be further compared to the natural history of the disease in a comparable group of patients during their waiting period who were not subject to the above intervention.
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
- •Age ≥ 18 years old
- •Patient sex - male and female
- •Diagnosis with indolent lymphoma in low-grade lymphoma (follicular lymphoma (FL), marginal zone lymphoma MZL), as assessed by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
- •Lack of need and non treatable patients at the time of diagnosis
- •Existence of detailed medical information about physical activity and dietary habits
- •Patients who have signed an informed consent form to participate in the study.
排除标准
- •Need for therapeutic intervention
- •Administration of chemotherapy and / or monoclonal antibodies or immunomodulatory preparation
- •Chronic inflammatory or infectious disease
- •Another malignant disease
- •Pregnant women, special populations - children and incapacitated of judgment
结局指标
主要结局
Partial remission or complete remission
时间窗: up to 36 months
Response will be assessed by the revised Lugano classification
Overall Response Rate
时间窗: up to 36 months
Overall Response Rate (ORR) defined as the proportion of patients who achieve complete response (CR) and partial response (PR) determined by PET-CT imaging according to the 2014 Lugano criteria assessing FDG-PET/CT in lymphoma
次要结局
- Progression Free Survival(up to 36 months)
- Disease Free Survival(up to 36 months)