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The aim of the study was to assess the effect of nutritional supplementation on nutritional status and postoperational complications in cancer patients with no clinical signs of malnutrition
In previous psychological studies our team found high level psychological stress in over 60% of cancer patients. This may cause numerous problems including anorexia, which together with biological disturbances can initiate cancer related catabolism even when it can not yet be seen. In this study we want to answer the question if oral nutritional supplementation can help the patient overcome the catabolism in its initial phase and improve nutritional status, which would result in reduced number of postoperational complications
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional supplements | Active Comparator | Patients are asked to drink two 200ml bottles of nutritional supplement daily |
|
| Control | No Intervention | Patients are asked to keep on to their normal diet. No supplementation is introduced |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional supplements | Dietary Supplement | Patients are asked to drink two 200ml bottles of nutritional supplement daily for 14 days before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of nutritional status | The aim of the study was to assess if nutritional supplementation improves nutritional status of patients with no clinical signs of malnutrition. Nutritional status improvement will be assessed by change in anthropometric (body weight (kg)) and laboratory (albumin, total protein, transferrin level, total lymphocyte count) parameters. | After 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reducing number of complications | To assess if improvement of nutritional status is connected with reduced number of postoperative complications. | 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paweł Kabata, MD | Contact | +48509707959 | pawel.kabata@gmail.com | |
| Tomasz Jastrzębski, Prof | Contact | +48583493190 | jasek@post.pl |
| Name | Affiliation | Role |
|---|---|---|
| Paweł Kabata, MD | Department of Surgical Oncology Medical University of Gdańsk | Principal Investigator |
| Tomasz Jastrzębski, Prof. | Department of Surgical Oncology Medical University of Gdańsk | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgical Oncology Medical University of Gdańsk | Recruiting | Gdansk | Pomeranian Voivodeship | 80-210 | Poland |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D000008 | Abdominal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| D009371 | Neoplasms by Site |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |