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Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

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ClinicalTrials.gov Identifier: NCT02585362
Recruitment Status : Completed
First Posted : October 23, 2015
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Winterthur KSW

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Gastro-Intestinal Cancer Breast Cancer Prostate Cancer Pleural Mesothelioma Urothelial Carcinoma Renal Cell Carcinoma Ovarian Cancer Behavioral: physical exercise Behavioral: nutrition counseling Dietary Supplement: whey protein supplement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Influence of a Specially Formulated Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program on Physical Performance in Cancer Outpatients
Actual Study Start Date : March 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018


Arm Intervention/treatment
Active Comparator: Intervention group
Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks
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

Behavioral: 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.

No Intervention: Control group
Participants will receive standard care



Primary Outcome Measures :
  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 Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585362


Locations
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Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Sponsors and Collaborators
Kantonsspital Winterthur KSW
Investigators
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Principal Investigator: Miklos Pless, Prof. Kantonsspital Winterthur KSW
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Responsible Party: Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT02585362    
Other Study ID Numbers: Leucine1.0
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kantonsspital Winterthur KSW:
palliative
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Mesothelioma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Adenoma
Neoplasms, Mesothelial
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases