Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer, Gastro-Intestinal Cancer, Breast Cancer, Prostate Cancer, Pleural Mesothelioma, Urothelial Carcinoma, Renal Cell Carcinoma, Ovarian Cancer

Intervention / Treatment
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* Behavioral: physical exercise
* Behavioral: nutrition counseling
* Dietary Supplement: whey protein supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks | Behavioral: physical exercise<br>* The standardized Training program will be performed twice a week in the Kantonsspital Winterthur and once a week in a home based setting<br>Behavioral: nutrition counseling<br>* At least 3 times, participants will receive nutrition counseling to improve energy- and protein intake<br>Dietary Supplement: whey protein supplement<br>* 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.<br>|
| No Intervention: Control group<br>Participants will receive standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical performance | 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 | Body composition will be assessed with bioimpedance | measured at week 0, 12 and 24 | 
| Change in quality of life | Quality of life will be assessed with the questerionnaire EORTC-QLQ-C30 | measured at week 0, 12 and 24 | 
| Change in fatigue | Fatigue will be assessed with the questionnaire brief fatigue inventory | measured at week 0, 12 and 24 | 
| Change in physical function | 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 | 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 | 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 | Number of re-hospitalization | up to 24 weeks | 
| Change in WHO performance status | Change in WHO performance status | measured at week 0, 12 and 24 | 
| Overall survival | Overall survival | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palliative