Ignite Creation Date:
2024-05-06 @ 2:32 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02066363
Status:
TERMINATED
Last Update Posted:
2017-10-05
First Post:
2014-02-14
Brief Title:
Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment very time consuming too few wanting participation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None