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Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

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.

Tracking Information
First Received DateOctober 13, 2015
Last Changed DateMay 11, 2017
Start DateMarch 2016
Anticipated Primary Completion DateJuly 2018
Primary Outcome Measures

Change in physical performance [Time Frame: measured at week 0, 12 and 24]

Secondary Outcome Measures

Change in body composition [Time Frame: measured at week 0, 12 and 24]

Change in quality of life [Time Frame: measured at week 0, 12 and 24]

Change in fatigue [Time Frame: measured at week 0, 12 and 24]

Change in physical function [Time Frame: measured at week 0, 12 and 24]

Change in nutritional status [Time Frame: measured at week 0, 12 and 24]

Change in diet history [Time Frame: measured at week 0, 12 and 24]

Number of re-hospitalization [Time Frame: up to 24 weeks]

Change in WHO performance status [Time Frame: measured at week 0, 12 and 24]

Overall survival [Time Frame: up to 24 weeks]

Descriptive Information
PhaseN/A
Study TypeInterventional
Condition
  • Lung Cancer
  • Gastro-Intestinal Cancer
  • Breast Cancer
  • Prostate Cancer
  • Pleural Mesothelioma
  • Urothelial Carcinoma
  • Renal Cell Carcinoma
  • Ovarian Cancer
Intervention
  • Behavioral: physical exercise
  • Behavioral: nutrition counseling
  • Dietary Supplement: whey protein supplement
Study Arms / Comparison Groups2 / 0
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.

Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment88
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Lena J Vogt
Email: lena.vogt@ksw.ch
Phone: +41 52 266 23 27
Eligibility Criteria

Inclusion Criteria:

- Advanced lung or gastrointestinal cancer patients not eligible for curative treatment

- 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

Administrative Information
NCTIDNCT02585362
Responsible Party,
SponsorKantonsspital Winterthur KSW
Verification DateMay 2017
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