Clinical trial NCT02437474: Impact of Elimination or Reduction of Dietary Animal Proteins on Cancer Progression and Survival - A Pilot Study
Official title: Impact of Elimination or Reduction of Dietary Animal Proteins on Cancer Progression and Survival - A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Keywords: vegan diet
lacto-ovo-vegetarian diet
cancer
tumor remission
Lead sponsor: Verein Essen und Krebs
Sponsor class: OTHER
Collaborators: name: University Hospital Regensburg
First posted: 2015-05-07
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be recruited in community via print media, internet and especially social media as well as referred by oncological clinics.

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).

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

Primary outcomes:
measure: Number / percentage of remissions
timeFrame: 6 months
Secondary outcomes:
measure: Tumor diagnosis and tumor behaviour (complete remission / partial remission / no change / progression)
timeFrame: 3 and 6 months (optional: 12 and 24 months)
measure: Relapse-free interval
timeFrame: 0, 3, 6, 12 and 24 months
measure: Therapies, therapy tolerability and side-effects (vomiting, nausea, hair loss, weakness, diarrhea, polyneuropathy,...)
timeFrame: 0, 3 and 6 months (optional: 12 and 24 months)
measure: Comorbidities
timeFrame: 0, 3 and 6 months (optional: 12 and 24 months)
measure: Medication
timeFrame: 0, 3 and 6 months (optional: 12 and 24 months)
measure: Quality of life
timeFrame: 0, 3 and 6 months (optional: 12 and 24 months)
measure: Acceptance and feasibility of the selected diet
timeFrame: 3 and 6 months (optional: 12 and 24 months)
measure: Dietary pattern
timeFrame: 0, 3, 6, 12 and 24 months
measure: Frequency, extent and duration of nutritional changes
timeFrame: 3 and 6 months (optional: 12 and 24 months)
measure: Weight and nutritional status
timeFrame: 0, 3, 6, 12 and 24 months
measure: Experience with / performance of study platform
timeFrame: 0, 3 and 6 months
measure: Validity checks for self reported data
timeFrame: 0, 3 and 6 months
measure: Survival rates for end stages
timeFrame: 6 months, 12 and 24 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Verein Essen und Krebs
Study officials:
affiliation: Registered Association "Food and Cancer"
name: Rosa Aspalter, MD
role: STUDY_DIRECTOR
References:
citation: Catany Ritter A, Egger AS, Machacek J, Aspalter R. Impact of Elimination or Reduction of Dietary Animal Proteins on Cancer Progression and Survival: Protocol of an Online Pilot Cohort Study. JMIR Res Protoc. 2016 Jul 29;5(3):e157. doi: 10.2196/resprot.5804.