The aim of the randomized controlled study is to determine effects of an adjusted amount of oral nutritional supplements on the quality of life, the nutritional status, side effects, and response to therapy, in patients with pancreatic and hepatocellular carcinoma receiving palliative therapy.
Cancer is often associated with malnutrition and weight loss. The occurence of malnutrition during the course of the disease depends on the type, extent, and therapy of the tumor. Pancreatic cancer patients and patients with hepatocellular carcinoma are particularly at risk of developing a pronounced weight loss. Cancer-related malnutrition has negative impact on the response to therapy, survival, quality of life, and the infection rate of patients, resulting in prolonged hospital stays and higher costs for health care. Maintaining or optimizing the quality of life in patients receiving palliative therapy has priority. Since a poor nutritional status affects the quality of life, patients might benefit from the use of an adjusted amount of oral nutritional supplements. To determine the effects of oral nutritional supplements, a controlled randomized study will be conducted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
Beginning with the start of palliative therapy, depending on the nutritional status, one, two, or three cans per day are ingested during a period of three months.
Change in health-related quality of life
Health-related quality of life is assessed by using the standardized questionnaire "Short Form-36 Health Survey" (SF36).
Time frame: Every four weeks for a period of three months and after six months
Change in disease-related quality of life
Disease-related quality of life is assessed by using the standardized questionnaire "Functional Assessment of Cancer Therapy - Hepatobiliary questionaire" (FACT-Hep).
Time frame: Every four weeks for a period of three months and after six months
Body mass index (BMI)
To calculate the BMI, weight and height are measured.
Time frame: Every four weeks for a period of three months and after six months
Body composition
To measure the body composition, a bioelectrical impedance analysis (BIA) is carried out. The phase angle and the extracellular cell mass/body cell mass ratio (ECM/BCM ratio) is evaluated.
Time frame: Every four weeks for a period of three months and after six months
Grip strength [lb]
To measure the grip strength, a hydraulic force measuring device is used.
Time frame: Every four weeks for a period of three months and after six months
Score (points) of nutritional risk screening
Patients are screened with the Nutritional Risk Screening 2002 (NRS 2002)
Time frame: Every four weeks for a period of three months and after six months
Laboratory parameters
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Albumin, C-reactive protein (CRP), Ferritin are measured to assess the nutritional and protein status as well as the disease activity
Time frame: Every four weeks for a period of three months and after six months