Nutritional Supplementation in Patients With no Signs of Malnutrition
- Conditions
- Secondary NeoplasmAbdominal NeoplasmPrimary Neoplasm
- Registration Number
- NCT01894828
- Lead Sponsor
- MedSource Polska
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Primary or secondary resectable gastrointestinal and abdominal malignancy
- No signs of malnutrition at qualification for surgery
- General performance >70 Karnofsky scale
- Informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Improvement of nutritional status 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 Outcome Measures
Name Time Method Reducing number of complications 30 days after surgery To assess if improvement of nutritional status is connected with reduced number of postoperative complications.
Related Research Topics
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Trial Locations
- Locations (1)
Department of Surgical Oncology Medical University of Gdańsk
🇵🇱Gdańsk, Pomorskie, Poland
Department of Surgical Oncology Medical University of Gdańsk🇵🇱Gdańsk, Pomorskie, PolandPaweł Kabata, MDPrincipal InvestigatorTomasz Jastrzębski, ProfPrincipal InvestigatorMichał Kąkol, MDSub InvestigatorKarolina Król, MScSub Investigator