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

Rosa Aspalter

Status: Completed

Conditions: Neoplasms

Treatments: Behavioral: Lacto-ovo-vegetarian diet; Behavioral: Omnivorous diet; Behavioral: Vegan diet

Study type: Observational

Funder types: Other

Identifiers

NCT02437474

EK-01

Details and patient eligibility

About

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

Full description

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).

Enrollment: 326 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

326 participants in 3 patient groups

Omnivorous diet

Description:

Participants are consuming meat, fish, milk/milk products, eggs, plant products.

Treatment:

Behavioral: Omnivorous diet

Lacto-ovo-vegetarian diet

Description:

Participants are consuming milk/milk products, eggs, plant products but no meat, fish or by-products.

Treatment:

Behavioral: Lacto-ovo-vegetarian diet

Vegan diet

Description:

Participants are consuming plant products but no meat, fish, milk/milk products, eggs or by-products as well as honey.

Treatment:

Behavioral: Vegan diet