NeoplasmsNCT02437474
Impact of Elimination or Reduction of Dietary Animal Proteins on Cancer Progression and Survival - A Pilot Study
An observational study of Neoplasms, run by Rosa Aspalter at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Omnivorous diet, Lacto-ovo-vegetarian diet and Vegan diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 326 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will be recruited in community via print media, internet and especially social media as well as referred by oncological clinics.
Who may be able to join
- Diagnosis of cancer
- Age >18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
Read the 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).
- Conditions
- Neoplasms
- Being tested
- Omnivorous diet, Lacto-ovo-vegetarian diet, Vegan diet
- Keywords
- vegan diet, lacto-ovo-vegetarian diet, cancer, tumor remission
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnivorous dietBehavioural
Adopting or continuing the selected diet for 6 months (omnivorous)
Lacto-ovo-vegetarian dietBehavioural
Adopting or continuing the selected diet for 6 months (lacto-ovo-vegetarian)
Vegan dietBehavioural
Adopting or continuing the selected diet for 6 months (vegan)
| Study group | Role | What they receive |
|---|---|---|
| Omnivorous diet | Participants are consuming meat, fish, milk/milk products, eggs, plant products. Receives: Behavioral: Omnivorous diet | |
| Lacto-ovo-vegetarian diet | Participants are consuming milk/milk products, eggs, plant products but no meat, fish or by-products. Receives: 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. Receives: Behavioral: Vegan diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number / percentage of remissions
Percentages of remissions as defined be complete absence of a tumor - in an ITT (intention to treat) analysis
Measured: 6 months
Secondary outcomes (13)
Tumor diagnosis and tumor behaviour (complete remission / partial remission / no change / progression)
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.
Measured: 3 and 6 months (optional: 12 and 24 months)
Relapse-free interval
A relapse is defined by a recurrence of a tumor after a tumor free interval.
Measured: 0, 3, 6, 12 and 24 months
Therapies, therapy tolerability and side-effects (vomiting, nausea, hair loss, weakness, diarrhea, polyneuropathy,...)
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.
Measured: 0, 3 and 6 months (optional: 12 and 24 months)
Comorbidities
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.
Measured: 0, 3 and 6 months (optional: 12 and 24 months)
Medication
The study questionnaire contains questions referring medications and supplements and the dosage.
Measured: 0, 3 and 6 months (optional: 12 and 24 months)
Quality of life
The study questionnaire contains questions referring quality of live covering the Karnofsky Index, but additional dimensions, too (psychosocial wellbeing).
Measured: 0, 3 and 6 months (optional: 12 and 24 months)
Acceptance and feasibility of the selected diet
The study questionnaire contains questions referring ease and difficulties with the selected diet.
Measured: 3 and 6 months (optional: 12 and 24 months)
Dietary pattern
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.
Measured: 0, 3, 6, 12 and 24 months
Frequency, extent and duration of nutritional changes
The results referring to nutrition and dietary patterns are evaluated in terms of change and duration of change in dietary patterns (in months).
Measured: 3 and 6 months (optional: 12 and 24 months)
Weight and nutritional status
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.
Measured: 0, 3, 6, 12 and 24 months
Experience with / performance of study platform
One question of the questionnaire asks for experience and usability of the comprehensive questionnaire in terms of content, understanding, effort und technical experience.
Measured: 0, 3 and 6 months
Validity checks for self reported data
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.
Measured: 0, 3 and 6 months
Survival rates for end stages
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).
Measured: 6 months, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosa Aspalter
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Regensburg
- Responsible party
- Sponsor-investigator, Rosa Aspalter, Verein Essen und Krebs
- Investigators
- Rosa Aspalter, MD, Study director, Registered Association "Food and Cancer"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437474
- Sponsor's protocol ID
- EK-01
- Status last verified
- Nov 2017
- First submitted
- 16 Apr 2015
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27473726
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Elimination or Reduction of Dietary Animal Proteins on Cancer Progression and Survival - A Pilot Study
- ClinicalTrials.gov ID
- NCT02437474
- Acronym / sponsor ID
- EK-01
- Conditions
- Neoplasms
- Keywords
- vegan diet, lacto-ovo-vegetarian diet, cancer, tumor remission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Rosa AspalterUniversity, hospital or other
- Collaborators
- University Hospital Regensburg
- Study start
- Apr 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omnivorous diet | – | Behavioral: Omnivorous dietParticipants are consuming meat, fish, milk/milk products, eggs, plant products. |
| Lacto-ovo-vegetarian diet | – | Behavioral: Lacto-ovo-vegetarian dietParticipants are consuming milk/milk products, eggs, plant products but no meat, fish or by-products. |
| Vegan diet | – | Behavioral: Vegan dietParticipants are consuming plant products but no meat, fish, milk/milk products, eggs or by-products as well as honey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be recruited in community via print media, internet and especially social media as well as referred by oncological clinics.
Key inclusion criteria (2 listed)
- Diagnosis of cancer
- Age >18 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnivorous dietAdopting or continuing the selected diet for 6 months (omnivorous) | Behavioural | Omnivorous diet |
| Lacto-ovo-vegetarian dietAdopting or continuing the selected diet for 6 months (lacto-ovo-vegetarian) | Behavioural | Lacto-ovo-vegetarian diet |
| Vegan dietAdopting or continuing the selected diet for 6 months (vegan) | Behavioural | Vegan diet |
Primary outcome
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
13 secondary outcomes
Tumor diagnosis and tumor behaviour (complete remission / partial remission / no change / progression)
Time frame: 3 and 6 months (optional: 12 and 24 months)
Relapse-free interval
Time frame: 0, 3, 6, 12 and 24 months
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)
Comorbidities
Time frame: 0, 3 and 6 months (optional: 12 and 24 months)
Medication
Time frame: 0, 3 and 6 months (optional: 12 and 24 months)
Quality of life
Time frame: 0, 3 and 6 months (optional: 12 and 24 months)
Acceptance and feasibility of the selected diet
Time frame: 3 and 6 months (optional: 12 and 24 months)
Dietary pattern
Time frame: 0, 3, 6, 12 and 24 months
Frequency, extent and duration of nutritional changes
Time frame: 3 and 6 months (optional: 12 and 24 months)
Weight and nutritional status
Time frame: 0, 3, 6, 12 and 24 months
Experience with / performance of study platform
Time frame: 0, 3 and 6 months
Validity checks for self reported data
Time frame: 0, 3 and 6 months
Survival rates for end stages
Time frame: 6 months, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Derived from this study: PubMed 27473726Catany 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Aspalter, MD study director
Registered Association "Food and Cancer"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by Rosa Aspalter at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number / percentage of remissions (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02437474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.