Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

Not Applicable

Completed

• Conditions: Lung Cancer; Gastro-Intestinal Cancer; Breast Cancer; Ovarian Cancer; Prostate Cancer; Urothelial Carcinoma; Renal Cell Carcinoma; Pleural Mesothelioma
• Interventions: Behavioral: physical exercise; Behavioral: nutrition counseling; Dietary Supplement: whey protein supplement

• Registration Number: NCT02585362
• Lead Sponsor: Kantonsspital Winterthur KSW

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Study Start: 2016-03
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	physical exercise	Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks
Intervention group	nutrition counseling	Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks
Intervention group	whey protein supplement	Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in physical performance	measured at week 0, 12 and 24	Physical performance will be assessed with the short physical performance battery

Secondary Outcome Measures

Name	Time	Method
Change in nutritional status	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
Number of re-hospitalization	up to 24 weeks	Number of re-hospitalization
Change in physical function	measured at week 0, 12 and 24	Physical function will be assessed with 60s-sit-to-stand-test and timed-up\&go-test
Change in diet history	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
Overall survival	up to 24 weeks	Overall survival
Change in body composition	measured at week 0, 12 and 24	Body composition will be assessed with bioimpedance
Change in quality of life	measured at week 0, 12 and 24	Quality of life will be assessed with the questerionnaire EORTC-QLQ-C30
Change in fatigue	measured at week 0, 12 and 24	Fatigue will be assessed with the questionnaire brief fatigue inventory
Change in WHO performance status	measured at week 0, 12 and 24	Change in WHO performance status

Trial Locations

Locations (1)

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland