- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02437474
Impact of Elimination or Reduction of Dietary Animal Proteins on Cancer Progression and Survival - A Pilot Study
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
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Vienna, Austria, 1060
- Verein Essen und Krebs
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Omnivorous diet
Participants are consuming meat, fish, milk/milk products, eggs, plant products.
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Adopting or continuing the selected diet for 6 months (omnivorous)
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Lacto-ovo-vegetarian diet
Participants are consuming milk/milk products, eggs, plant products but no meat, fish or by-products.
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Adopting or continuing the selected diet for 6 months (lacto-ovo-vegetarian)
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Vegan diet
Participants are consuming plant products but no meat, fish, milk/milk products, eggs or by-products as well as honey.
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Adopting or continuing the selected diet for 6 months (vegan)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number / percentage of remissions
Time Frame: 6 months
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Percentages of remissions as defined be complete absence of a tumor - in an ITT (intention to treat) analysis
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor diagnosis and tumor behaviour (complete remission / partial remission / no change / progression)
Time Frame: 3 and 6 months (optional: 12 and 24 months)
|
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.
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3 and 6 months (optional: 12 and 24 months)
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Relapse-free interval
Time Frame: 0, 3, 6, 12 and 24 months
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A relapse is defined by a recurrence of a tumor after a tumor free interval.
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0, 3, 6, 12 and 24 months
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Therapies, therapy tolerability and side-effects (vomiting, nausea, hair loss, weakness, diarrhea, polyneuropathy,...)
Time Frame: 0, 3 and 6 months (optional: 12 and 24 months)
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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.
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0, 3 and 6 months (optional: 12 and 24 months)
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Comorbidities
Time Frame: 0, 3 and 6 months (optional: 12 and 24 months)
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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.
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0, 3 and 6 months (optional: 12 and 24 months)
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Medication
Time Frame: 0, 3 and 6 months (optional: 12 and 24 months)
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The study questionnaire contains questions referring medications and supplements and the dosage.
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0, 3 and 6 months (optional: 12 and 24 months)
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Quality of life
Time Frame: 0, 3 and 6 months (optional: 12 and 24 months)
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The study questionnaire contains questions referring quality of live covering the Karnofsky Index, but additional dimensions, too (psychosocial wellbeing).
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0, 3 and 6 months (optional: 12 and 24 months)
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Acceptance and feasibility of the selected diet
Time Frame: 3 and 6 months (optional: 12 and 24 months)
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The study questionnaire contains questions referring ease and difficulties with the selected diet.
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3 and 6 months (optional: 12 and 24 months)
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Dietary pattern
Time Frame: 0, 3, 6, 12 and 24 months
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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
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Frequency, extent and duration of nutritional changes
Time Frame: 3 and 6 months (optional: 12 and 24 months)
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The results referring to nutrition and dietary patterns are evaluated in terms of change and duration of change in dietary patterns (in months).
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3 and 6 months (optional: 12 and 24 months)
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Weight and nutritional status
Time Frame: 0, 3, 6, 12 and 24 months
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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.
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0, 3, 6, 12 and 24 months
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Experience with / performance of study platform
Time Frame: 0, 3 and 6 months
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One question of the questionnaire asks for experience and usability of the comprehensive questionnaire in terms of content, understanding, effort und technical experience.
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0, 3 and 6 months
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Validity checks for self reported data
Time Frame: 0, 3 and 6 months
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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.
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0, 3 and 6 months
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Survival rates for end stages
Time Frame: 6 months, 12 and 24 months
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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).
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6 months, 12 and 24 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Rosa Aspalter, MD, Registered Association "Food and Cancer"
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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