Study Stopped
Recruitment very time consuming, too few wanting participation
Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer
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
1 other identifier
interventional
47
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2017
CompletedOctober 5, 2017
October 1, 2017
3.5 years
February 14, 2014
October 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in body composition
Measured by using bioelectrical impedance analysis.
Six months
Secondary Outcomes (1)
Time to to exacerbate Quality of Life
six months
Other Outcomes (2)
frequency of readmission to the Hospital
6 months
Survival in study
6 months
Study Arms (2)
Best nutritional Care
ACTIVE COMPARATORBest supportive nutritional care and dietician advise
Parenteral nutrition
EXPERIMENTALSupplemental 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.
Interventions
Dietician advise 5 times, during 24weeks. Prescription of a diet plan if wanted from the patient.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Gastrointestinal obstruction or failure.
- Immune deficiency diseases (apart from the cancer disease. )
- Current infection or sepsis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- Baxter Healthcare Corporationcollaborator
- Region of Southern Denmarkcollaborator
- Danish Cancer Societycollaborator
- Aase and Ejnar Danielsens Foundationcollaborator
- Hartmann Fondencollaborator
- Knud and Edith Eriksen Memorial Fundcollaborator
- Merchant M. Brogaard and Wife Memorial fundcollaborator
- Odense Patient Data Explorative Networkcollaborator
Study Sites (1)
Odense University Hospital
Odense, 5000, Denmark
Related Publications (1)
Obling SR, Wilson BV, Pfeiffer P, Kjeldsen J. Home parenteral nutrition increases fat free mass in patients with incurable gastrointestinal cancer. Results of a randomized controlled trial. Clin Nutr. 2019 Feb;38(1):182-190. doi: 10.1016/j.clnu.2017.12.011. Epub 2017 Dec 21.
PMID: 29305245DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jens Kjeldsen, ph.d
Odense University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Registrar, ph.d student
Study Record Dates
First Submitted
February 14, 2014
First Posted
February 19, 2014
Study Start
March 1, 2014
Primary Completion
August 30, 2017
Study Completion
August 30, 2017
Last Updated
October 5, 2017
Record last verified: 2017-10