Brief Title
Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program
Official Title
Influence of a Specially Formulated Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program on Physical Performance in Cancer Outpatients
Brief Summary
This study evaluates physical performance in cancer outpatients during a multimodal therapy.
Half of the patients will receive physical exercise und nutrition program in combination with
a specially formulated whey protein supplement, while the other half will receive standard
care.
Detailed Description
The time period of Intervention will last 3 month, measurements will be conducted at baseline
and 3 month. After 6 month there will be an additional follow-up test point to assess the
sustainability of the intervention. The 3-month intervention study consists of a physical
exercise program and nutrition counseling in combination with a specially formulated whey
protein supplement high in leucine. The standardized training program will be performed twice
a week in the physical department of the Kantonsspital Winterthur (KSW) and once a week in a
home based setting. Additionally, participants of the intervention group will be aks to
consume 15 g of the nutrient supplement powder with approximately 150 ml water. On workout
days the supplement should be taken twice a day and on the remaining days once a day. During
the three month intervention study participants will take part in a nutrition counseling for
at least three times.
Study Type
Interventional
Primary Outcome
Change in physical performance
Secondary Outcome
Change in body composition
Condition
Lung Cancer
Intervention
physical exercise
Study Arms / Comparison Groups
Intervention group
Description: Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
52
Start Date
March 2016
Completion Date
October 2018
Primary Completion Date
October 2018
Eligibility Criteria
Inclusion Criteria:
- Advanced cancer patients not eligible for curative treatment: lung cancer,
gastrointestinal cancer, breast cancer, prostate cancer, ovarian cancer, pleural
mesothelioma, urothelium carcinoma, renal cell carcinoma
- WHO performance status ≥ 2
- Able to walk independently at least 100 meters
- Estimated life expectancy of ≥ 6 month
Exclusion Criteria:
- Patients currently using nutritional supplements with branched chain amino acids
- Enteral or parenteral nutrition within 1 month
- History of ileus within 1 month
- Psychiatric disorder precluding understanding of information on trials related topics
and giving informed consent
- Milk protein allergy
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Miklos Pless, Prof., ,
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT02585362
Organization ID
Leucine1.0
Responsible Party
Sponsor
Study Sponsor
Kantonsspital Winterthur KSW
Study Sponsor
Miklos Pless, Prof., Principal Investigator, Kantonsspital Winterthur KSW
Verification Date
January 2019