2015-01
2016-01
2016-01
80
NCT02312674
University of Hohenheim
University of Hohenheim
INTERVENTIONAL
Prevention of Cancer-associated Malnutrition Through Oral Nutritional Supplements
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-11-07 | N/A | 2014-12-08 |
2014-12-08 | N/A | 2014-12-09 |
2014-12-09 | N/A | 2014-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Intervention Patient group which takes daily an adjusted amount of oral nutritional supplements through an intervention period of three months | DIETARY_SUPPLEMENT: Oral nutritional supplement
|
| NO_INTERVENTION: Control Patients group which takes no oral nutritional supplements |
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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. | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Stephan C. Bischoff, MD, Prof. Phone Number: 0049 711 45924101 Email: bischoff.stephan@uni-hohenheim.de |
Study Contact Backup Name: Janna Jayme Phone Number: Email: janna.jayme@uni-hohenheim.de |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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