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

Percentages of remissions as defined be complete absence of a tumor - in an ITT (intention to treat) analysis

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.

A relapse is defined by a recurrence of a tumor after a tumor free interval.

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.

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.

The study questionnaire contains questions referring medications and supplements and the dosage.

The study questionnaire contains questions referring quality of live covering the Karnofsky Index, but additional dimensions, too (psychosocial wellbeing).

The study questionnaire contains questions referring ease and difficulties with the selected diet.

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.

The results referring to nutrition and dietary patterns are evaluated in terms of change and duration of change in dietary patterns (in months).

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.

One question of the questionnaire asks for experience and usability of the comprehensive questionnaire in terms of content, understanding, effort und technical experience.

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.

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).