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JOURNAL ONKOLOGIE – STUDIE

Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

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NCT-Nummer:
NCT02585362

Studienbeginn:
März 2016

Letztes Update:
11.01.2019

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Renal Cell, Mesothelioma, Carcinoma, Transitional Cell, Intestinal Neoplasms, Gastrointestinal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Kantonsspital Winterthur KSW

Collaborator:
-

Studienleiter

Miklos Pless, Prof.
Principal Investigator
Kantonsspital Winterthur KSW

Studienlocations
(1 von 1)

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Change in physical performance (Time Frame - measured at week 0, 12 and 24):
Physical performance will be assessed with the short physical performance battery



Secondary outcome:

1. Change in body composition (Time Frame - measured at week 0, 12 and 24):
Body composition will be assessed with bioimpedance

2. Change in quality of life (Time Frame - measured at week 0, 12 and 24):
Quality of life will be assessed with the questerionnaire EORTC-QLQ-C30

3. Change in fatigue (Time Frame - measured at week 0, 12 and 24):
Fatigue will be assessed with the questionnaire brief fatigue inventory

4. Change in physical function (Time Frame - measured at week 0, 12 and 24):
Physical function will be assessed with 60s-sit-to-stand-test and timed-up&go-test

5. Change in nutritional status (Time Frame - measured at week 0, 12 and 24):
Nutritional status will be assessed with hand grip, nutritional risk screening 2002 and patient-generated subjective global assessment

6. Change in diet history (Time Frame - measured at week 0, 12 and 24):
3-day food records brought in at weeks 0, 12 and 24 will be analyzed for energy- and protein intakes

7. Number of re-hospitalization (Time Frame - up to 24 weeks):
Number of re-hospitalization

8. Change in WHO performance status (Time Frame - measured at week 0, 12 and 24):
Change in WHO performance status

9. Overall survival (Time Frame - up to 24 weeks):
Overall survival

Studien-Arme

  • Active Comparator: Intervention group
    Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks
  • No Intervention: Control group
    Participants will receive standard care

Geprüfte Regime

  • 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
  • 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.

Quelle: ClinicalTrials.gov


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