title: Impact of Elimination or Reduction of Dietary Animal Proteins on Cancer Progression and Survival: Protocol of an Online Pilot Cohort Study.
abstract: BACKGROUND
  Current evidence suggests that the incidence of cancer is low in vegan populations, and experimental studies have revealed a significant role of dietary proteins in cancer development and progression. However, little data currently exists regarding the effect of a plant-based diet on the progression of diagnosed cancer.
  
  
  OBJECTIVE
  The main objective of this study is to determine if a reduction or total elimination of animal protein from the diet can positively influence the outcome of an existing cancer and, in addition to standard oncological therapies, increase remission rates.
  
  
  METHODS
  The primary aim of this online study is to test the effect on remission rates in cancer patients (primary outcome) with distinct self-selected dietary patterns (omnivore, lacto-ovo-vegetarian, vegan), and allow for an estimation of the effect size. Secondary outcomes are tumor behavior, relapse-free interval, therapies, therapy tolerability and side-effects, comorbidities, medication, quality of life, acceptance, and feasibility of the selected diet. Safety concerns exist for vegan diets (especially in cancer patients) and the study will carefully monitor for deterioration of health, tumor progression, or malnutrition. Furthermore, the study will evaluate the online portal as a study platform (technical and safety aspects, and sequence of displayed questionnaires) as well as the validity of self-reported and online-generated data.
  
  
  RESULTS
  The study was performed between April, 2015 and June, 2016, and a preliminary evaluation of safety aspects was undertaken after June, 2016. Primary and secondary outcomes will be evaluated when the final patients complete the study in December, 2016.
  
  
  CONCLUSIONS
  This study will reveal information about the effects of dietary patterns on cancer disease and progression. The methodology of the study addresses several aspects and limitations of nutrition studies in cancer patients, such as precision of nutrition data, acceptance criteria, online methodology, and safety aspects.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT02437474; https://clinicaltrials.gov/ct2/show/NCT02437474 (Archived by WebCite at http://www.webcitation.org/6jL7UUCVq).
authors.affiliation: Association for Research and Support of Health Promoting Nutrition during Cancer Disease, Vienna, Austria.
authors.forename: Anna
authors.identifier: http://orcid.org/0000-0003-1289-2483
authors.initials: A
authors.lastname: Catany Ritter
authors.forename: Annarita Sabrina
authors.identifier: http://orcid.org/0000-0002-5067-0008
authors.initials: AS
authors.lastname: Egger
authors.forename: Jennifer
authors.identifier: http://orcid.org/0000-0001-6269-5600
authors.initials: J
authors.lastname: Machacek
authors.forename: Rosa
authors.identifier: http://orcid.org/0000-0002-0871-1929
authors.initials: R
authors.lastname: Aspalter
keywords: cancer; diet; disease outcome; neoplasms; omnivore; remission; vegans; vegetarians