Quality of Life Clinical Trial
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
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.
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