Back to resultsNutritional Supplementation in Patients With no Signs of Malnutrition
Primary Purpose
Primary Neoplasm, Secondary Neoplasm, Abdominal Neoplasm
Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Nutritional supplements
Sponsored by
About this trial
This is an interventional supportive care trial for Primary Neoplasm focused on measuring Nutritional support, Gastrointestinal cancer, Malnutrition
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
Sites / Locations
- Department of Surgical Oncology Medical University of GdańskRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Nutritional supplements
Control
Arm Description
Patients are asked to drink two 200ml bottles of nutritional supplement daily
Patients are asked to keep on to their normal diet. No supplementation is introduced
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Reducing number of complications
To assess if improvement of nutritional status is connected with reduced number of postoperative complications.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01894828
Brief Title
Nutritional Supplementation in Patients With no Signs of Malnutrition
Official Title
The Effect of Nutritional Supplementation in Cancer Patients With no Clinical Signs of Malnutrition
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedSource Polska
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Neoplasm, Secondary Neoplasm, Abdominal Neoplasm
Keywords
Nutritional support, Gastrointestinal cancer, Malnutrition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nutritional supplements
Arm Type
Active Comparator
Arm Description
Patients are asked to drink two 200ml bottles of nutritional supplement daily
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients are asked to keep on to their normal diet. No supplementation is introduced
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional supplements
Intervention Description
Patients are asked to drink two 200ml bottles of nutritional supplement daily for 14 days before surgery
Primary Outcome Measure Information:
Title
Improvement of nutritional status
Description
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.
Time Frame
After 14 days
Secondary Outcome Measure Information:
Title
Reducing number of complications
Description
To assess if improvement of nutritional status is connected with reduced number of postoperative complications.
Time Frame
30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paweł Kabata, MD
Phone
+48509707959
Email
pawel.kabata@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tomasz Jastrzębski, Prof
Phone
+48583493190
Email
jasek@post.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paweł Kabata, MD
Organizational Affiliation
Department of Surgical Oncology Medical University of Gdańsk
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tomasz Jastrzębski, Prof.
Organizational Affiliation
Department of Surgical Oncology Medical University of Gdańsk
Official's Role
Study Director
Facility Information:
Facility Name
Department of Surgical Oncology Medical University of Gdańsk
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-210
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paweł Kabata, MD
Phone
+48509707959
Email
pawel.kabata@gmail.com
First Name & Middle Initial & Last Name & Degree
Paweł Kabata, MD
First Name & Middle Initial & Last Name & Degree
Tomasz Jastrzębski, Prof
First Name & Middle Initial & Last Name & Degree
Michał Kąkol, MD
First Name & Middle Initial & Last Name & Degree
Karolina Król, MSc
12. IPD Sharing Statement
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Nutritional Supplementation in Patients With no Signs of Malnutrition
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