Nutritional Supplementation in Patients With no Signs of Malnutrition

Phase 4

• Conditions: Secondary Neoplasm; Abdominal Neoplasm; Primary Neoplasm
• Interventions: Dietary Supplement: Nutritional supplements

• 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

Study Timeline

• Study Start: 2011-04
• Status Verified: 2013-07
• Study First Submitted: 2013-07-04
• Study First Submitted QC: 2013-07-09
• Last Update Submitted: 2013-07-09
• Study First Posted: 2013-07-10
• Last Update Posted: 2013-07-10
• Primary Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional supplements	Nutritional supplements	Patients are asked to drink two 200ml bottles of nutritional supplement daily

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.

Trial Locations

Locations (1)

Department of Surgical Oncology Medical University of Gdańsk; 🇵🇱 Gdańsk, Pomorskie, Poland