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

Rosa Aspalter1 site in 1 country326 target enrollmentApril 2015

ConditionsNeoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neoplasms
Sponsor: Rosa Aspalter
Enrollment: 326
Locations: 1
Primary Endpoint: Number / percentage of remissions
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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).

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

December 2016

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Rosa Aspalter

Responsible Party

Sponsor Investigator

Principal Investigator

Rosa Aspalter

Director of Research

Verein Essen und Krebs

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number / percentage of remissions

Time Frame: 6 months

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

Secondary Outcomes

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)