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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437474
• Other study ID #: EK-01
• Status: Completed
• Phase: N/A
• First received: April 16, 2015
• Last updated: November 5, 2017
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2017
• Source: Verein Essen und Krebs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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, 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Behavioral:
• Omnivorous diet
Adopting or continuing the selected diet for 6 months (omnivorous)
• Lacto-ovo-vegetarian diet
Adopting or continuing the selected diet for 6 months (lacto-ovo-vegetarian)
• Vegan diet
Adopting or continuing the selected diet for 6 months (vegan)

Locations

Country	Name	City	State
Austria	Verein Essen und Krebs	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Rosa Aspalter	University Hospital Regensburg

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3 and 6 months (optional: 12 and 24 months)
Secondary	Relapse-free interval	A relapse is defined by a recurrence of a tumor after a tumor free interval.	0, 3, 6, 12 and 24 months
Secondary	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.	0, 3 and 6 months (optional: 12 and 24 months)
Secondary	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.	0, 3 and 6 months (optional: 12 and 24 months)
Secondary	Medication	The study questionnaire contains questions referring medications and supplements and the dosage.	0, 3 and 6 months (optional: 12 and 24 months)
Secondary	Quality of life	The study questionnaire contains questions referring quality of live covering the Karnofsky Index, but additional dimensions, too (psychosocial wellbeing).	0, 3 and 6 months (optional: 12 and 24 months)
Secondary	Acceptance and feasibility of the selected diet	The study questionnaire contains questions referring ease and difficulties with the selected diet.	3 and 6 months (optional: 12 and 24 months)
Secondary	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.	0, 3, 6, 12 and 24 months
Secondary	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).	3 and 6 months (optional: 12 and 24 months)
Secondary	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.	0, 3, 6, 12 and 24 months
Secondary	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.	0, 3 and 6 months
Secondary	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.	0, 3 and 6 months
Secondary	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).	6 months, 12 and 24 months

External Links

•   Project website www.foodandcancer.net or www.essenundkrebs.net