Clinical trial NCT02066363: Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastrointestinal Cancer
Dietary Modification
Cancer Cachexia
Quality of Life
Body Composition, Beneficial
Keywords: Bioelectrical impedance
Parenteral nutrition
Malnutrition
Quality of life.
Cancer cachexia
Body composition
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
name: Region of Southern Denmark
name: Danish Cancer Society
name: Aase and Ejnar Danielsens Foundation
name: Hartmann Fonden
name: Knud and Edith Eriksen Memorial Fund
name: Merchant M. Brogaard and Wife Memorial fund
name: Odense Patient Data Explorative Network
First posted: 2014-02-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in body composition
timeFrame: Six months
Secondary outcomes:
measure: Time to to exacerbate Quality of Life
timeFrame: six months
Other outcomes:
measure: frequency of readmission to the Hospital
timeFrame: 6 months
measure: Survival in study
timeFrame: 6 months
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Jens Kjeldsen, ph.d
role: STUDY_DIRECTOR
References:
citation: 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.