Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

January 10, 2019 updated by: Kantonsspital Winterthur KSW

Influence of a Specially Formulated Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program on Physical Performance in Cancer Outpatients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Winterthur, Switzerland, 8401
        • Kantonsspital Winterthur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group
Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks
Behavioral: physical exercise
The standardized Training program will be performed twice a week in the Kantonsspital Winterthur and once a week in a home based setting
Behavioral: nutrition counseling
At least 3 times, participants will receive nutrition counseling to improve energy- and protein intake
Dietary supplement: whey protein supplement
On workout days study participants will consume twice a day 15 g of the supplement powder with approximately 150 ml water. On the remaining days participants consume the supplement once a day.
No Intervention: Control group
Participants will receive standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in physical performance
Time Frame: measured at week 0, 12 and 24
Physical performance will be assessed with the short physical performance battery
measured at week 0, 12 and 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body composition
Time Frame: measured at week 0, 12 and 24
Body composition will be assessed with bioimpedance
measured at week 0, 12 and 24
Change in quality of life
Time Frame: measured at week 0, 12 and 24
Quality of life will be assessed with the questerionnaire EORTC-QLQ-C30
measured at week 0, 12 and 24
Change in fatigue
Time Frame: measured at week 0, 12 and 24
Fatigue will be assessed with the questionnaire brief fatigue inventory
measured at week 0, 12 and 24
Change in physical function
Time Frame: measured at week 0, 12 and 24
Physical function will be assessed with 60s-sit-to-stand-test and timed-up&go-test
measured at week 0, 12 and 24
Change in nutritional status
Time Frame: measured at week 0, 12 and 24
Nutritional status will be assessed with hand grip, nutritional risk screening 2002 and patient-generated subjective global assessment
measured at week 0, 12 and 24
Change in diet history
Time Frame: measured at week 0, 12 and 24
3-day food records brought in at weeks 0, 12 and 24 will be analyzed for energy- and protein intakes
measured at week 0, 12 and 24
Number of re-hospitalization
Time Frame: up to 24 weeks
Number of re-hospitalization
up to 24 weeks
Change in WHO performance status
Time Frame: measured at week 0, 12 and 24
Change in WHO performance status
measured at week 0, 12 and 24
Overall survival
Time Frame: up to 24 weeks
Overall survival
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Winterthur KSW

Investigators

  • Principal Investigator: Miklos Pless, Prof., Kantonsspital Winterthur KSW

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 23, 2015

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Leucine1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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