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

NCT02437474 | Completed DMC

• 1 other identifier: EK-01
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 1

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

Conditions

Neoplasms

Keywords

vegan diet; lacto-ovo-vegetarian diet; cancer; tumor remission

Outcome Measures

Primary Outcomes (1)

• Number / percentage of remissions

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

  6 months

Secondary Outcomes (13)

• Tumor diagnosis and tumor behaviour (complete remission / partial remission / no change / progression)

  3 and 6 months (optional: 12 and 24 months)

• Relapse-free interval

  0, 3, 6, 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)

• Comorbidities

  0, 3 and 6 months (optional: 12 and 24 months)

• Medication

  0, 3 and 6 months (optional: 12 and 24 months)

Study Arms (3)

Omnivorous diet

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

Behavioral: Omnivorous diet

Lacto-ovo-vegetarian diet

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

Behavioral: Lacto-ovo-vegetarian diet

Vegan diet

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

Behavioral: Vegan diet

Interventions

Omnivorous diet BEHAVIORAL

Adopting or continuing the selected diet for 6 months (omnivorous)

Omnivorous diet

Lacto-ovo-vegetarian diet BEHAVIORAL

Adopting or continuing the selected diet for 6 months (lacto-ovo-vegetarian)

Lacto-ovo-vegetarian diet

Vegan diet BEHAVIORAL

Adopting or continuing the selected diet for 6 months (vegan)

Vegan diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosis of cancer
• Age \>18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Rosa Aspalter: lead
• University Hospital Regensburg: collaborator

Study Sites (1)

Verein Essen und Krebs

Vienna, 1060, Austria

Location

Related Publications (1)

• 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.

  PMID: 27473726 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Diet, Vegetarian; Diet, Vegan

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Rosa Aspalter, MD

  Registered Association "Food and Cancer"

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: May 7, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 7, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)