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| Name | Class |
|---|---|
| Nutricia Foundation | OTHER |
Determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy.
Other endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NUTRIDRINK Compact Protein | Active Comparator | NUTRIDRINK Compact Protein Oral nutritional supplement Dietary advice |
|
| without oral nutritional supplements | No Intervention | Dietary advice alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NUTRIDRINK Compact Protein | Dietary Supplement | high-energy, high-protein, oral liquid nutritional supplement; dosage: 2x125 ml per day, 7 days per week for 12 weeks (3 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy-related toxicity during 12th week of observation | graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 4.0); to determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy during 3 months observation period (comparison of the results at the baseline and after 12 weeks) | at baseline and after 12th week |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Nutritional status / metabolic status | the assessment according to Nutritional Risk Screening 2002 (NRS 2002), Subjective Global Assessment (SGA), body mass, body mass index (BMI), VAS for appetite, albumin, prealbumin, triglycerides, total cholesterol, fasting blood glucose, C-reactive protein (CRP), ferritin, complete blood count. Body mass (in kg) will measure by the scales (Tanita BC 420). Hight ( in cm) measure by Stadiometer (Tanita) Body mass index calculation (BMI) on the basis of the following formula: BMI = body weight / height2 (kg/m2). VAS for appetite is 100-mm line where 0 mm means "I had no appetite at all" and 100 mm means "My appetite was very good". Laboratory parameters will measured by routine laboratory methods. All results will be compared between study groups (ONS vs without ONS) at the same time point (eg. baseline group ONS vs baseline group without ONS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sylwia Malgorzewicz, MD, PhD | Contact | +48 58 3492724 | sylwiam@gumed.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Sylwia Malgorzewicz, MD, PhD | University Clinical Centre, Gdansk, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Centre | Recruiting | Gdansk | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41599804 | Derived | Zietarska M, Malgorzewicz S. Quality of Life of Colorectal Cancer Patients Treated with Chemotherapy. Nutrients. 2026 Jan 7;18(2):191. doi: 10.3390/nu18020191. |
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publication in nutritional and oncological journals, presentation on the congresses
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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|
| at baseline and after 12th week |
| Changes in the Quality of life and patients well-being | FAACT-ESPEN score Version 4 (Functional Assessment of Anorexia/Cachexia Therapy questionnaire) is a measure of the quality of life and it is completed by a patient, it has a total of 42 questions. Patients mark 0 (none) - 4 (very much) for each question. This tool consists of five subscales: functional well-being (7 items), physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items) and other aspects, including appetite (13 items). The maximum score is 168. The lower the score, the lower overall quality of life. | at baseline and after 12th week |
| Changes in the Performance status | To performance status assessment will be used Kornofsky scale and ECOG scale. The Karnofsky score allows to quantify the overall state and quality of life of a patient with neoplastic disease who qualifies to receive chemotherapy. The score has a range from 0 to 100, where 100 represents the ideal state and 0 - death. The Eastern Cooperative Oncology Group(ECOG) score runs from 0 to 5, with 0 denoting perfect health and 5 death. | at baseline and after 12th week |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |