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Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer

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ClinicalTrials.gov Identifier: NCT02066363
Recruitment Status : Terminated (Recruitment very time consuming, too few wanting participation)
First Posted : February 19, 2014
Last Update Posted : October 5, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Gastrointestinal Cancer Dietary Modification Cancer Cachexia Quality of Life Body Composition, Beneficial Dietary Supplement: Dietician advise Dietary Supplement: Parenteral nutrition

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : March 1, 2014
Primary Completion Date : August 30, 2017
Study Completion Date : August 30, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Best supportive Nutritional care,
Dietary Supplement: Parenteral nutrition
Supportive parenteral nutrition.

Outcome Measures

Primary Outcome Measures :
  1. Changes in body composition [ Time Frame: Six months ]
    Measured by using bioelectrical impedance analysis.

Secondary Outcome Measures :
  1. 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)

Other Outcome Measures:
  1. frequency of readmission to the Hospital [ Time Frame: 6 months ]
    Number of admissions

  2. Survival in study [ Time Frame: 6 months ]
    Time to event; survival time in study

Eligibility Criteria

Information from the National Library of Medicine

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

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.
Contacts and Locations

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): NCT02066363

Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Baxter Healthcare Corporation
Region of Southern Denmark
Danish Cancer Society
Aase and Ejnar Danielsens Foundation
Brødrene Hartmanns Fond
Knud and Edith Eriksen Memorial Fund
Merchant M. Brogaard and Wife Memorial fund
OPEN, Odense Patient data Explorative Network, OUH
Study Director: Jens Kjeldsen, ph.d Odense University Hospital
More Information

Responsible Party: Sine Obling, MD, Registrar, ph.d student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02066363     History of Changes
Other Study ID Numbers: HPN 01
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Sine Obling, MD, Odense University Hospital:
Bioelectrical impedance
Parenteral nutrition
Quality of life.
Cancer cachexia
Body composition

Additional relevant MeSH terms:
Wasting Syndrome
Gastrointestinal Neoplasms
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases