Nutritional Supplementation in Patients With no Signs of Malnutrition

Study 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

Official Title
-----------------
The Effect of Nutritional Supplementation in Cancer Patients With no Clinical Signs of Malnutrition

Conditions
-----------------
Primary Neoplasm, Secondary Neoplasm, Abdominal Neoplasm

Intervention / Treatment
-----------------
* Dietary Supplement: Nutritional supplements


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutritional supplements<br>Patients are asked to drink two 200ml bottles of nutritional supplement daily | Dietary Supplement: Nutritional supplements<br>* Patients are asked to drink two 200ml bottles of nutritional supplement daily for 14 days before surgery<br>|
| No Intervention: Control<br>Patients are asked to keep on to their normal diet. No supplementation is introduced | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutritional support, Gastrointestinal cancer, Malnutrition