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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks |
|
| Control group | No Intervention | Participants will receive standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical performance | Physical performance will be assessed with the short physical performance battery | measured at week 0, 12 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body composition | Body composition will be assessed with bioimpedance | measured at week 0, 12 and 24 |
| Change in quality of life | Quality of life will be assessed with the questerionnaire EORTC-QLQ-C30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miklos Pless, Prof. | Kantonsspital Winterthur KSW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Winterthur | Winterthur | 8401 | Switzerland |
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| 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. |
|
| measured at week 0, 12 and 24 |
| Change in fatigue | Fatigue will be assessed with the questionnaire brief fatigue inventory | measured at week 0, 12 and 24 |
| 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 |
| 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 |
| 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 |
| Number of re-hospitalization | Number of re-hospitalization | up to 24 weeks |
| Change in WHO performance status | Change in WHO performance status | measured at week 0, 12 and 24 |
| Overall survival | Overall survival | up to 24 weeks |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D000086002 | Mesothelioma, Malignant |
| D002295 | Carcinoma, Transitional Cell |
| D002292 | Carcinoma, Renal Cell |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D010997 | Pleural Neoplasms |
| D002277 | Carcinoma |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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