Cancer
Conditions
Keywords
pancreatic carcinoma, hepatocellular carcinoma, palliative therapy, oral nutritional supplements, quality of life, nutritional status
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.
Interventions
DIETARY_SUPPLEMENTOral nutritional supplement
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.
Sponsors
University Hospital Tuebingen
University of Hohenheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | After three months | In patients with pancreatic cancer tumor staging is performed based on the Response Evaluation Criteria in Solid Tumors (RECIST criteria), in patients with hepatocellular carcinoma tumor staging is performed based on the modified RECIST criteria |
| Dose density | After three months | The dose density is determined by the intended and actual administered respectively ingested dose of medication. The dose density is taken from the chemotherapy protocols or determined based on taking notes. |
| Average daily energy intake [kcal] | Every four weeks for a period of three months and after six months | To assess the average daily energy intake patients keep a food diary over two days between the trial dates |
| Side effect profile | Every four weeks for a period of three months and after six months | The occurrence and extent of tumor-associated and nutritional therapy-associated side effects are determined using Common Terminology Criteria for Adverse Events (CTCAE) |
Contacts
Primary ContactStephan C. Bischoff, MD, Prof.
Backup ContactJanna Jayme
Outcome results
None listed