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Nutritional Supplementation in Patients With no Signs of Malnutrition

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ClinicalTrials.gov Identifier: NCT01894828
Recruitment Status : Unknown
Verified July 2013 by MedSource Polska.
Recruitment status was:  Recruiting
First Posted : July 10, 2013
Last Update Posted : July 10, 2013
Sponsor:
Information provided by (Responsible Party):
MedSource Polska

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

Condition or disease Intervention/treatment Phase
Primary Neoplasm Secondary Neoplasm Abdominal Neoplasm Dietary Supplement: Nutritional supplements Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Nutritional Supplementation in Cancer Patients With no Clinical Signs of Malnutrition
Study Start Date : April 2011
Estimated Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894828


Contacts
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Contact: Paweł Kabata, MD +48509707959 pawel.kabata@gmail.com
Contact: Tomasz Jastrzębski, Prof +48583493190 jasek@post.pl

Locations
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Poland
Department of Surgical Oncology Medical University of Gdańsk Recruiting
Gdańsk, Pomorskie, Poland, 80-210
Contact: Paweł Kabata, MD    +48509707959    pawel.kabata@gmail.com   
Principal Investigator: Paweł Kabata, MD         
Principal Investigator: Tomasz Jastrzębski, Prof         
Sub-Investigator: Michał Kąkol, MD         
Sub-Investigator: Karolina Król, MSc         
Sponsors and Collaborators
MedSource Polska
Investigators
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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
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Responsible Party: MedSource Polska
ClinicalTrials.gov Identifier: NCT01894828    
Other Study ID Numbers: Nutri01
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: July 2013
Keywords provided by MedSource Polska:
Nutritional support
Gastrointestinal cancer
Malnutrition
Additional relevant MeSH terms:
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Neoplasms
Abdominal Neoplasms
Malnutrition
Nutrition Disorders
Neoplasms by Site