Clinical trial NCT02585362: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Gastro-Intestinal Cancer
Breast Cancer
Prostate Cancer
Pleural Mesothelioma
Urothelial Carcinoma
Renal Cell Carcinoma
Ovarian Cancer
Keywords: palliative
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in physical performance
timeFrame: measured at week 0, 12 and 24
Secondary outcomes:
measure: Change in body composition
timeFrame: measured at week 0, 12 and 24
measure: Change in quality of life
timeFrame: measured at week 0, 12 and 24
measure: Change in fatigue
timeFrame: measured at week 0, 12 and 24
measure: Change in physical function
timeFrame: measured at week 0, 12 and 24
measure: Change in nutritional status
timeFrame: measured at week 0, 12 and 24
measure: Change in diet history
timeFrame: measured at week 0, 12 and 24
measure: Number of re-hospitalization
timeFrame: up to 24 weeks
measure: Change in WHO performance status
timeFrame: measured at week 0, 12 and 24
measure: Overall survival
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
Study officials:
affiliation: Kantonsspital Winterthur KSW
name: Miklos Pless, Prof.
role: PRINCIPAL_INVESTIGATOR
References: