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
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).
Study Type
OBSERVATIONAL
Enrollment
326
Adopting or continuing the selected diet for 6 months (omnivorous)
Adopting or continuing the selected diet for 6 months (lacto-ovo-vegetarian)
Adopting or continuing the selected diet for 6 months (vegan)
Verein Essen und Krebs
Vienna, Austria
Number / percentage of remissions
Percentages of remissions as defined be complete absence of a tumor - in an ITT (intention to treat) analysis
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0, 3 and 6 months (optional: 12 and 24 months)
Medication
The study questionnaire contains questions referring medications and supplements and the dosage.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 6 months, 12 and 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.