The Effect of Nutritional Supplementation in Cancer Patients With no Clinical Signs of Malnutrition
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Primary Neoplasm
- Sponsor
- MedSource Polska
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Improvement of nutritional status
- Last Updated
- 12 years ago
Overview
Brief Summary
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
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Primary or secondary resectable gastrointestinal and abdominal malignancy
- •No signs of malnutrition at qualification for surgery
- •General performance \>70 Karnofsky scale
- •Informed consent
Exclusion Criteria
- •history of radio or chemotherapy
- •signs of mechanical ileus
- •other major gastrointestinal diseases
- •type 1 diabetes
- •autoimmunological diseases requiring systemic steroids
- •signs of infection
- •renal and/or liver failure
Outcomes
Primary Outcomes
Improvement of nutritional status
Time Frame: After 14 days
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.
Secondary Outcomes
- Reducing number of complications(30 days after surgery)