Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer

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.

Conditions

• Gastrointestinal Cancer
• Dietary Modification
• Cancer Cachexia
• Quality of Life
• Body Composition, Beneficial

Interventions

DIETARY_SUPPLEMENT

Dietician advise

Dietician advise 5 times, during 24weeks. Prescription of a diet plan if wanted from the patient.

DIETARY_SUPPLEMENT

Parenteral nutrition

Supportive parenteral nutrition.

Sponsors & Collaborators

• Baxter Healthcare Corporation

  collaborator INDUSTRY

• Region of Southern Denmark

  collaborator OTHER

• Danish Cancer Society

  collaborator OTHER

• Aase and Ejnar Danielsens Foundation

  collaborator OTHER

• Hartmann Fonden

  collaborator OTHER

• Knud and Edith Eriksen Memorial Fund

  collaborator UNKNOWN

• Merchant M. Brogaard and Wife Memorial fund

  collaborator UNKNOWN

• Odense Patient Data Explorative Network

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Jens Kjeldsen, ph.d · Odense University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-01

Primary Completion

2017-08-30

Completion

2017-08-30

Countries

• Denmark

Study Locations