Impact of Elimination or Reduction of Dietary Animal Proteins on Cancer Progression and Survival - A Pilot Study

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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Impact of Elimination or Reduction of Dietary Animal Proteins on Cancer Progression and Survival - A Pilot Study

Conditions
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Neoplasms

Intervention / Treatment
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* Behavioral: Omnivorous diet
* Behavioral: Lacto-ovo-vegetarian diet
* Behavioral: Vegan diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cancer Inclusion in a tumor treatment or follow-up program Age >18 years Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Omnivorous diet<br>Participants are consuming meat, fish, milk/milk products, eggs, plant products. | Behavioral: Omnivorous diet<br>* Adopting or continuing the selected diet for 6 months (omnivorous)<br>|
| Lacto-ovo-vegetarian diet<br>Participants are consuming milk/milk products, eggs, plant products but no meat, fish or by-products. | Behavioral: Lacto-ovo-vegetarian diet<br>* Adopting or continuing the selected diet for 6 months (lacto-ovo-vegetarian)<br>|
| Vegan diet<br>Participants are consuming plant products but no meat, fish, milk/milk products, eggs or by-products as well as honey. | Behavioral: Vegan diet<br>* Adopting or continuing the selected diet for 6 months (vegan)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number / percentage of remissions | Percentages of remissions as defined be complete absence of a tumor - in an ITT (intention to treat) analysis | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor diagnosis and tumor behaviour (complete remission / partial remission / no change / progression) | In the fist questionnaire, tumor history (diagnosis, classification, stage, previous therapy) is entered. At months 0, 3, 6, 12 and 24 tumor stage at present time is asked again. Comparing the staging between time points, tumor behaviour is categorized into four groups: complete remission / partial remission / no change / tumor progression. This will be determined for each participant by two investigator independently. | 3 and 6 months (optional: 12 and 24 months) | 
| Relapse-free interval | A relapse is defined by a recurrence of a tumor after a tumor free interval. | 0, 3, 6, 12 and 24 months | 
| Therapies, therapy tolerability and side-effects (vomiting, nausea, hair loss, weakness, diarrhea, polyneuropathy,...) | The study questionnaire contains questions referring frequently occuring symptoms in cancer patients and wether they are related to a certain therapy or to other factors. The option others is included in case the present symptoms are not covered by the listed symptoms. | 0, 3 and 6 months (optional: 12 and 24 months) | 
| Comorbidities | The study questionnaire contains questions referring frequently occuring diseases other than cancer and wether they are present now or were present in the past. The option others is included in case the present disease is not covered by the listed diseases. | 0, 3 and 6 months (optional: 12 and 24 months) | 
| Medication | The study questionnaire contains questions referring medications and supplements and the dosage. | 0, 3 and 6 months (optional: 12 and 24 months) | 
| Quality of life | The study questionnaire contains questions referring quality of live covering the Karnofsky Index, but additional dimensions, too (psychosocial wellbeing). | 0, 3 and 6 months (optional: 12 and 24 months) | 
| Acceptance and feasibility of the selected diet | The study questionnaire contains questions referring ease and difficulties with the selected diet. | 3 and 6 months (optional: 12 and 24 months) | 
| Dietary pattern | The study questionnaire contains questions referring previous dietary patterns and the dietary pattern which will be followed for the time of study participation (6 months) as well as the reason for choosing the respective diet. There is a categorical question asking for dietary patterns as well a comprehensive food frequency questionnaire especially adopted for discrimination of plant an animal derived foods. In addition to the main study questionnaires, participants are asked to report any unplanned change in their diet during study participation. | 0, 3, 6, 12 and 24 months | 
| Frequency, extent and duration of nutritional changes | The results referring to nutrition and dietary patterns are evaluated in terms of change and duration of change in dietary patterns (in months). | 3 and 6 months (optional: 12 and 24 months) | 
| Weight and nutritional status | Weight is entered in kg and size in cm. BMI is calculated. Nutritional status is derived from weight changes, laboratory test results (albumin) and questions referring to eating problems contained in the study questionnaire. | 0, 3, 6, 12 and 24 months | 
| Experience with / performance of study platform | One question of the questionnaire asks for experience and usability of the comprehensive questionnaire in terms of content, understanding, effort und technical experience. | 0, 3 and 6 months | 
| Validity checks for self reported data | Several questions are repeated in the questionnaire in a slightly different way to check for consistency. Dietary patterns are checked via food frequency questionnaires and control questions in the laboratory test section. | 0, 3 and 6 months | 
| Survival rates for end stages | Survival rates are calculated from the participants still alive and dead. In case of a pending questionnaire a contact person is asked or a cancer registry checked (depending on the citizenship of the participant). | 6 months, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vegan diet, lacto-ovo-vegetarian diet, cancer, tumor remission