Prevention of Malnutrition Through Oral Nutritional Supplements in Cancer Patients Receiving Palliative Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- University of Hohenheim
- Enrollment
- 80
- Primary Endpoint
- Change in disease-related quality of life
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in disease-related quality of life
Time Frame: 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
Time Frame: 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 Outcomes
- Body mass index (BMI)(Every four weeks for a period of three months and after six months)
- Body composition(Every four weeks for a period of three months and after six months)
- Grip strength [lb](Every four weeks for a period of three months and after six months)
- Score (points) of nutritional risk screening(Every four weeks for a period of three months and after six months)
- Laboratory parameters(Every four weeks for a period of three months and after six months)