Nutritional Supplementation in Patients With no Signs of Malnutrition

July 9, 2013 updated by: MedSource Polska

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-210
        • Recruiting
        • Department of Surgical Oncology Medical University of Gdańsk
        • Contact:
        • Principal Investigator:
          • Paweł Kabata, MD
        • Principal Investigator:
          • Tomasz Jastrzębski, Prof
        • Sub-Investigator:
          • Michał Kąkol, MD
        • Sub-Investigator:
          • Karolina Król, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nutritional supplements
Patients are asked to drink two 200ml bottles of nutritional supplement daily
Dietary supplement: Nutritional supplements
Patients are asked to drink two 200ml bottles of nutritional supplement daily for 14 days before surgery
No Intervention: Control
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
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.
After 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reducing number of complications
Time Frame: 30 days after surgery
To assess if improvement of nutritional status is connected with reduced number of postoperative complications.
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedSource Polska

Investigators

  • Principal Investigator: Paweł Kabata, MD, Department of Surgical Oncology Medical University of Gdańsk
  • Study Director: Tomasz Jastrzębski, Prof., Department of Surgical Oncology Medical University of Gdańsk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nutri01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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