Clinical trial NCT02312674: Prevention of Cancer-associated Malnutrition Through Oral Nutritional Supplements
Official title: Prevention of Malnutrition Through Oral Nutritional Supplements in Cancer Patients Receiving Palliative Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: pancreatic carcinoma
hepatocellular carcinoma
palliative therapy
oral nutritional supplements
quality of life
nutritional status
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2014-12-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in health-related quality of life
timeFrame: Every four weeks for a period of three months and after six months
measure: Change in disease-related quality of life
timeFrame: Every four weeks for a period of three months and after six months
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: Every four weeks for a period of three months and after six months
measure: Body composition
timeFrame: Every four weeks for a period of three months and after six months
measure: Grip strength [lb]
timeFrame: Every four weeks for a period of three months and after six months
measure: Score (points) of nutritional risk screening
timeFrame: Every four weeks for a period of three months and after six months
measure: Laboratory parameters
timeFrame: Every four weeks for a period of three months and after six months
Other outcomes:
measure: Average daily energy intake [kcal]
timeFrame: Every four weeks for a period of three months and after six months
measure: Side effect profile
timeFrame: Every four weeks for a period of three months and after six months
measure: Dose density
timeFrame: After three months
measure: Tumor response
timeFrame: After three months
Locations:
Study officials:
affiliation: Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
name: Stephan C. Bischoff, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Hepatology, Gastroenterology, Infectious Diseases, University Hospital Tübingen
name: Michael Bitzer, MD; Prof.
role: STUDY_DIRECTOR
References: