Nutritional Supplementation in Patients With no Signs of Malnutrition

Abdominal Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01894828
• Other study ID #: Nutri01
• Status: Recruiting
• Phase: Phase 4
• First received: July 4, 2013
• Last updated: July 9, 2013
• Start date: April 2011

Study information

• Verified date: July 2013
• Source: MedSource Polska
• Contact: Pawel Kabata, MD
• Phone: +48509707959
• Email: pawel.kabata[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Abdominal Neoplasm
• Abdominal Neoplasms
• Malnutrition
• Neoplasms
• Primary Neoplasm
• Secondary Neoplasm

Intervention

Dietary Supplement:
• Nutritional supplements
Patients are asked to drink two 200ml bottles of nutritional supplement daily for 14 days before surgery

Locations

Country	Name	City	State
Poland	Department of Surgical Oncology Medical University of Gdansk	Gdansk	Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
MedSource Polska

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Reducing number of complications	To assess if improvement of nutritional status is connected with reduced number of postoperative complications.	30 days after surgery	No