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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
Sponsor:
Collaborators:
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
Odense Patient Data Explorative Network
Information provided by (Responsible Party):
Sine Obling, MD, Odense University Hospital

February 14, 2014
February 19, 2014
October 5, 2017
March 1, 2014
August 30, 2017   (Final data collection date for primary outcome measure)
Changes in body composition [ Time Frame: Six months ]
Measured by using bioelectrical impedance analysis.
Same as current
Complete list of historical versions of study NCT02066363 on ClinicalTrials.gov Archive Site
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)
Time to to exacerbate Quality of Life [ Time Frame: six months ]
Assesment of quality of Life by EORTC questionaire QLQ30
  • frequency of readmission to the Hospital [ Time Frame: 6 months ]
    Number of admissions
  • Survival in study [ Time Frame: 6 months ]
    Time to event; survival time in study
frequency of readmission to the Hospital [ Time Frame: 6 months ]
 
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

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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Gastrointestinal Cancer
  • Dietary Modification
  • Cancer Cachexia
  • Quality of Life
  • Body Composition, Beneficial
  • 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.
  • Active Comparator: Best nutritional Care
    Best supportive nutritional care and dietician advise
    Intervention: Dietary Supplement: Dietician advise
  • 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.
    Interventions:
    • Dietary Supplement: Dietician advise
    • Dietary Supplement: Parenteral nutrition
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. 2017 Dec 21. pii: S0261-5614(17)31431-0. doi: 10.1016/j.clnu.2017.12.011. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
47
100
August 30, 2017
August 30, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT02066363
HPN 01
Yes
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
Plan to Share IPD: Undecided
Sine Obling, MD, Odense University Hospital
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
  • Odense Patient Data Explorative Network
Study Director: Jens Kjeldsen, ph.d Odense University Hospital
Odense University Hospital
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP