Nutritional Supplementation in Patients With no Signs of Malnutrition

NCT01894828 | Unknown Phase 4 DMC

• 1 other identifier: Nutri01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Neoplasm; Secondary Neoplasm; Abdominal Neoplasm

Keywords

Nutritional support; Gastrointestinal cancer; Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reducing number of complications

  30 days after surgery

Study Arms (2)

Nutritional supplements

ACTIVE COMPARATOR

Patients are asked to drink two 200ml bottles of nutritional supplement daily

Dietary Supplement: Nutritional supplements

Control

NO INTERVENTION

Patients are asked to keep on to their normal diet. No supplementation is introduced

Interventions

Nutritional supplements DIETARY_SUPPLEMENT

Patients are asked to drink two 200ml bottles of nutritional supplement daily for 14 days before surgery

Nutritional supplements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary or secondary resectable gastrointestinal and abdominal malignancy
• No signs of malnutrition at qualification for surgery
• General performance \>70 Karnofsky scale
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• MedSource Polska: lead

Study Sites (1)

Department of Surgical Oncology Medical University of Gdańsk

Gdansk, Pomeranian Voivodeship, 80-210, Poland

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Abdominal Neoplasms; Gastrointestinal Neoplasms; Malnutrition

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Paweł Kabata, MD

  Department of Surgical Oncology Medical University of Gdańsk

  PRINCIPAL INVESTIGATOR

• Tomasz Jastrzębski, Prof.

  Department of Surgical Oncology Medical University of Gdańsk

  STUDY DIRECTOR

Central Study Contacts

Paweł Kabata, MD

CONTACT

+48509707959; pawel.kabata@gmail.com

Tomasz Jastrzębski, Prof

CONTACT

+48583493190; jasek@post.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2013
• First Posted: July 10, 2013
• Study Start: April 1, 2011
• Primary Completion: August 1, 2013
• Last Updated: July 10, 2013

Record last verified: 2013-07

Locations

PL (1)