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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01894828
Other study ID # Nutri01
Secondary ID
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. completion date
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


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
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