Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

Kantonsspital Winterthur KSW

Status: Completed

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

Treatments: Dietary Supplement: whey protein supplement; Behavioral: nutrition counseling; Behavioral: physical exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02585362

Leucine1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks

Treatment:

Behavioral: nutrition counseling

Dietary Supplement: whey protein supplement

Behavioral: physical exercise

Control group

No Intervention group

Description:

Participants will receive standard care