Breast Cancer, Gastro-Intestinal Cancer, Lung Cancer, Ovarian Cancer, Pleural Mesothelioma, Prostate Cancer, Renal Cell Carcinoma, Urothelial Carcinoma
Conditions
Keywords
palliative
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.
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.
Interventions
BEHAVIORALphysical exercise
The standardized Training program will be performed twice a week in the Kantonsspital Winterthur and once a week in a home based setting
BEHAVIORALnutrition counseling
At least 3 times, participants will receive nutrition counseling to improve energy- and protein intake
DIETARY_SUPPLEMENTwhey 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.
Sponsors
Kantonsspital Winterthur KSW
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical performance | measured at week 0, 12 and 24 | Physical performance will be assessed with the short physical performance battery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | measured at week 0, 12 and 24 | Quality of life will be assessed with the questerionnaire EORTC-QLQ-C30 |
| Change in fatigue | measured at week 0, 12 and 24 | Fatigue will be assessed with the questionnaire brief fatigue inventory |
| Change in physical function | measured at week 0, 12 and 24 | Physical function will be assessed with 60s-sit-to-stand-test and timed-up&go-test |
| Change in nutritional status | 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 |
| Change in body composition | measured at week 0, 12 and 24 | Body composition will be assessed with bioimpedance |
| Number of re-hospitalization | up to 24 weeks | Number of re-hospitalization |
| Change in WHO performance status | measured at week 0, 12 and 24 | Change in WHO performance status |
| Overall survival | up to 24 weeks | Overall survival |
| Change in diet history | 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 |
Countries
Switzerland
Outcome results
None listed