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Malnutrition and low muscle mass (sarcopenia) are common problems in patients with cancer. However, a low muscle mass is associated with negative clinical outcomes in patients with cancer. Therefore, it is very important to maintain muscle mass in this population. This study aims to investigate the effect of an oral nutritional supplement on skeletal muscle mass during anti-cancer treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental | An enriched high protein and high energy oral nutrition supplement (ONS) |
|
| Control product | Active Comparator | standard isocaloric high energy normal protein isocaloric ONS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| an enriched high protein and high energy oral nutrition supplement (ONS) | Dietary Supplement | NA (see intervention name) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cross-sectional skeletal muscle mass area on the third vertebral level (L3) [cm2] | between baseline and after 12 weeks of intervention as measured with a CT scan, between the two interventions | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in health-related quality of life as measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30 global health score) | between baseline and end of study [score], between the two interventions. | ~13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in health-related quality of life as measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30 global health score) | between baseline and end of study | ~13 weeks |
| Inflammation status |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danone Nutricia Research | Contact | +31 30 2095 000 | register.clinicalresearchnutricia@danone.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCC | Recruiting | Cork | Ireland |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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at baseline, visit 2, visit 3 and end of study (visit 5):
|
| ~13 weeks |
| Change in performance status ECOG | between baseline and end of study [score] | ~13 weeks |
| Change in physical function | between baseline and end of study: 30 seconds chair stand test [number] | ~13 weeks |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |