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NCT Number: NCT02585362

Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

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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Key information

Conditions

Lung Cancer Adenocarcinoma Adenoma Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Renal Cell Carcinoma, Transitional Cell Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastro-Intestinal Cancer Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pleural Mesothelioma Pleural Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise

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

Behavioral

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

Whey Protein Supplement

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kantonsspital Winterthur KSW

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 23, 2015
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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