Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-10-31

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type ACTIVE_COMPARATOR

physical exercise

Intervention Type BEHAVIORAL

The standardized Training program will be performed twice a week in the Kantonsspital Winterthur and once a week in a home based setting

nutrition counseling

Intervention Type BEHAVIORAL

At least 3 times, participants will receive nutrition counseling to improve energy- and protein intake

whey protein supplement

Intervention Type DIETARY_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.

Control group

Participants will receive standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

nutrition counseling

At least 3 times, participants will receive nutrition counseling to improve energy- and protein intake

Intervention Type BEHAVIORAL

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.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No