Nutritional Supplementation in Patients With no Signs of Malnutrition

NCT ID: NCT01894828

Last Updated: 2013-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Brief Summary

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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

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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

Conditions

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Primary Neoplasm Secondary Neoplasm Abdominal Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nutritional supplements

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

Group Type ACTIVE_COMPARATOR

Nutritional supplements

Intervention Type DIETARY_SUPPLEMENT

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nutritional supplements

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedSource Polska

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paweł Kabata, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgical Oncology Medical University of Gdańsk

Tomasz Jastrzębski, Prof.

Role: STUDY_DIRECTOR

Department of Surgical Oncology Medical University of Gdańsk

Locations

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Department of Surgical Oncology Medical University of Gdańsk

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Paweł Kabata, MD

Role: CONTACT

+48509707959

Tomasz Jastrzębski, Prof

Role: CONTACT

+48583493190

Facility Contacts

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Paweł Kabata, MD

Role: primary

+48509707959

Other Identifiers

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Nutri01

Identifier Type: -

Identifier Source: org_study_id

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