Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital Tuebingen | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patient group which takes daily an adjusted amount of oral nutritional supplements through an intervention period of three months |
|
| Control | No Intervention | Patients group which takes no oral nutritional supplements |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral nutritional supplement | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | Every four weeks for a period of three months and after six months |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index (BMI) | To calculate the BMI, weight and height are measured. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Average daily energy intake [kcal] | To assess the average daily energy intake patients keep a food diary over two days between the trial dates | Every four weeks for a period of three months and after six months |
| Side effect profile |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephan C. Bischoff, MD, Prof. | Contact | 0049 711 45924101 | bischoff.stephan@uni-hohenheim.de | |
| Janna Jayme | Contact | janna.jayme@uni-hohenheim.de |
| Name | Affiliation | Role |
|---|---|---|
| Stephan C. Bischoff, MD, Prof. | Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany | Principal Investigator |
| Michael Bitzer, MD; Prof. | Department of Hepatology, Gastroenterology, Infectious Diseases, University Hospital Tübingen |
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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) | Every four weeks for a period of three months and after six months |
| Laboratory parameters | Albumin, C-reactive protein (CRP), Ferritin are measured to assess the nutritional and protein status as well as the disease activity | 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)
| Every four weeks for a period of three months and after six months |
| Dose density | 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. | After three months |
| Tumor response | 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 | After three months |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |