Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer

October 4, 2017 updated by: Sine Obling, MD, Odense University Hospital

Best Nutritional Care in Cancer Patients. A Comparative Randomized Study of Supplemental Parenteral Nutrition to Patients With GI Cancer Compared to Best Supportive Nutritional Care

Clinical background: Weight loss is a common problem in patients suffering from gastrointestinal cancer. It is demonstrated that the prognosis for cancer patients with weight loss is worse than that for weight stable patients. Malnutrition in cancer patients is associated with a poor prognosis and is an important predictor of mortality. Supplementation with home parenteral nutrition in aphagic and terminal patients has shown improved quality of life, energy balance, body composition and prolonged survival.

Aim: The aim of this study is primarily to study the effects of supplementation with parenteral nutrition, to patients with advanced incurable gastrointestinal cancer on lean body-mass and body composition. Patients found to be at nutritional risk will be included in the study and will be randomized to either best supportive nutritional care or best supportive nutritional care and supplemental Parenteral Nutrition.

Design: This study is a controlled, randomized trial with two parallel study arms. The study will include patients with advanced GI cancers at nutritional risk, performance status 0-2 and with an expected survival of a minimum of 3 months.

A total of 100 patients are planned to be enrolled and randomized to either best supportive nutritional care or best supportive nutritional care and supplemental parenteral Nutrition.

Primary endpoint is improvement of lean body mass, and by that improvement of quality of life, performance status and cancer treatment tolerance.

Discussion: The planned study will provide important information about the effect of parenteral nutrition in a patient group with advanced gastrointestinal cancer. Palliative treatment strategies are set up to improve quality of life as well as prolongation of life. Parenteral nutrition in this patient group may indeed contribute to both these aspects of palliation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Randomizing. The patients will be enrolled in the study, by block randomizing using a computer generated list, stratifying in respect to performance status 0 and 1 in opposite to PS 2 for the first 10 patients enrolled in the study.

To make the two treatment groups comparable, the patients number 11-100 enrolled in the study will be placed in the treatment groups using the minimization method. Using the minimization method the prognostic factors for age, diagnosis and performance status at the enrollment, will be considered to make the treatment groups similar.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed non-resectable GI-Cancer
  • at nutritional risk; having lost 5% of body weight during the previous 3 months or has failed to reach intake by 25% in the last 2 weeks.
  • At performance status 0-2
  • Life expectancy more than 3 months.
  • Age over 18 years old.
  • Able to give written consent

Exclusion Criteria:

  • Gastrointestinal obstruction or failure.
  • Immune deficiency diseases (apart from the cancer disease. )
  • Current infection or sepsis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Best nutritional Care
Best supportive nutritional care and dietician advise
Dietary supplement: Dietician advise
Dietician advise 5 times, during 24weeks. Prescription of a diet plan if wanted from the patient.
Other Names:
  • Best supportive Nutritional care,
Experimental: Parenteral nutrition
Supplemental Parenteral Nutrition and dietician advise. Supplemental parenteral Nutrition 30% of estimated needs. Parenteral nutrition given at home, administered by a nurse. The patient will be seen at the Outpatient Clinic every 6th week, talk to dietician and a doctor.
Dietary supplement: Dietician advise
Dietician advise 5 times, during 24weeks. Prescription of a diet plan if wanted from the patient.
Other Names:
  • Best supportive Nutritional care,
Dietary supplement: Parenteral nutrition
Supportive parenteral nutrition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body composition
Time Frame: Six months
Measured by using bioelectrical impedance analysis.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to to exacerbate Quality of Life
Time Frame: six months
Assessment of quality of life by European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ30)
six months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of readmission to the Hospital
Time Frame: 6 months
Number of admissions
6 months
Survival in study
Time Frame: 6 months
Time to event; survival time in study
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

Baxter Healthcare Corporation
Danish Cancer Society
Region of Southern Denmark
Odense Patient Data Explorative Network
Hartmann Fonden
Aase and Ejnar Danielsens Foundation
Knud and Edith Eriksen Memorial Fund
Merchant M. Brogaard and Wife Memorial fund

Investigators

  • Study Director: Jens Kjeldsen, ph.d, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

August 30, 2017

Study Completion (Actual)

August 30, 2017

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Actual)

October 5, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPN 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on Dietician advise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe