Impact of Elimination or Reduction of Dietary Animal Proteins on Cancer Progression and Survival - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Number / percentage of remissions
研究概览
简要总结
The purposes of this study are
- to test the hypothesis that elimination or reduction of dietary animal proteins leads to an improved prognosis in tumor patients
- to estimate the effect size and thus to enable sample size calculations for further studies
- to test the feasibility and tolerance of different diets, especially a vegan diet, in cancer patients and to proof that a vegan diet does not lead to a deterioration of health, tumor progression or to malnutrition
- to test the online platform as a study platform
- to test validity of self reported and online generated data
详细描述
Participating cancer patients select one of 3 defined diets (omnivor/lacto-ovo-vegetarian/vegan) at baseline and will continue their prescribed oncological therapy at their attending physician/clinic.
Participants provide data (cancer history, tumor behavior, food frequency questionnaires, questionnaires referring to quality-of-life) at baseline and at 3 and 6 months with optional data entry points at 12 and 124 months and a follow up questionnaire at 12 and 24 months. Data is entered online via the study platforms www.essenundkrebs.net and www.foodandcancer.net in German and English language (no additional clinical visits are required).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of cancer
- •Inclusion in a tumor treatment or follow-up program
- •Age >18 years
排除标准
- •Psychiatric treatment during the last 3 months
- •Pregnancy
- •Breast feeding
- •BMI < 18,5 kg/m2
- •Major difficulties with food intake (swallowing, lack of appetite) limiting food intake
- •Participation in other studies requiring the attendance to a particular diet
结局指标
主要结局
Number / percentage of remissions
时间窗: 6 months
Percentages of remissions as defined be complete absence of a tumor - in an ITT (intention to treat) analysis
次要结局
- Relapse-free interval(0, 3, 6, 12 and 24 months)
- Comorbidities(0, 3 and 6 months (optional: 12 and 24 months))
- Quality of life(0, 3 and 6 months (optional: 12 and 24 months))
- Tumor diagnosis and tumor behaviour (complete remission / partial remission / no change / progression)(3 and 6 months (optional: 12 and 24 months))
- Frequency, extent and duration of nutritional changes(3 and 6 months (optional: 12 and 24 months))
- Dietary pattern(0, 3, 6, 12 and 24 months)
- Survival rates for end stages(6 months, 12 and 24 months)
- Therapies, therapy tolerability and side-effects (vomiting, nausea, hair loss, weakness, diarrhea, polyneuropathy,...)(0, 3 and 6 months (optional: 12 and 24 months))
- Medication(0, 3 and 6 months (optional: 12 and 24 months))
- Acceptance and feasibility of the selected diet(3 and 6 months (optional: 12 and 24 months))
- Weight and nutritional status(0, 3, 6, 12 and 24 months)
- Experience with / performance of study platform(0, 3 and 6 months)
- Validity checks for self reported data(0, 3 and 6 months)
研究者
Rosa Aspalter
Director of Research
Verein Essen und Krebs