Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585362
• Other study ID #: Leucine1.0
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: October 2018

Study information

• Verified date: January 2019
• Source: Kantonsspital Winterthur KSW
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma
• Carcinoma, Renal Cell
• Carcinoma, Transitional Cell
• Gastro-Intestinal Cancer
• Gastrointestinal Neoplasms
• Intestinal Neoplasms
• Lung Cancer
• Mesothelioma
• Ovarian Cancer
• Pleural Mesothelioma
• Prostate Cancer
• Renal Cell Carcinoma
• Urothelial Carcinoma

Intervention

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

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Winterthur	Winterthur

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical performance	Physical performance will be assessed with the short physical performance battery	measured at week 0, 12 and 24
Secondary	Change in body composition	Body composition will be assessed with bioimpedance	measured at week 0, 12 and 24
Secondary	Change in quality of life	Quality of life will be assessed with the questerionnaire EORTC-QLQ-C30	measured at week 0, 12 and 24
Secondary	Change in fatigue	Fatigue will be assessed with the questionnaire brief fatigue inventory	measured at week 0, 12 and 24
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of re-hospitalization	Number of re-hospitalization	up to 24 weeks
Secondary	Change in WHO performance status	Change in WHO performance status	measured at week 0, 12 and 24
Secondary	Overall survival	Overall survival	up to 24 weeks