Prevention of Cancer-associated Malnutrition Through Oral Nutritional Supplements
- Conditions
- Cancer
- Interventions
- Dietary Supplement: Oral nutritional supplement
- Registration Number
- NCT02312674
- Lead Sponsor
- University of Hohenheim
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- assured diagnosis of pancreatic cancer/hepatocellular carcinoma, not treatable with curative intent
- palliative systemic therapy of pancreatic cancer respectively palliative therapy of hepatocellular carcinoma with Sorafenib or TACE (transarterial chemoembolization)
- written informed consent prior to inclusion
- prefinal phase with an estimated life expectancy of less than three months
- nutritional support through tube feeding or a central venous catheter
- serious malassimilation (assessed by anamnesis)
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≥ 2
- hepatic encephalopathy ≥ degree 2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Oral nutritional supplement Patient group which takes daily an adjusted amount of oral nutritional supplements through an intervention period of three months
- Primary Outcome Measures
Name Time Method Change in disease-related quality of life Every four weeks for a period of three months and after six months Disease-related quality of life is assessed by using the standardized questionnaire "Functional Assessment of Cancer Therapy - Hepatobiliary questionaire" (FACT-Hep).
Change in health-related quality of life Every four weeks for a period of three months and after six months Health-related quality of life is assessed by using the standardized questionnaire "Short Form-36 Health Survey" (SF36).
- Secondary Outcome Measures
Name Time Method Body mass index (BMI) Every four weeks for a period of three months and after six months To calculate the BMI, weight and height are measured.
Body composition Every four weeks for a period of three months and after six months 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.
Grip strength [lb] Every four weeks for a period of three months and after six months To measure the grip strength, a hydraulic force measuring device is used.
Score (points) of nutritional risk screening Every four weeks for a period of three months and after six months Patients are screened with the Nutritional Risk Screening 2002 (NRS 2002)
Laboratory parameters Every four weeks for a period of three months and after six months Albumin, C-reactive protein (CRP), Ferritin are measured to assess the nutritional and protein status as well as the disease activity