Prevention of Cancer-associated Malnutrition Through Oral Nutritional Supplements

Prevention of Malnutrition Through Oral Nutritional Supplements in Cancer Patients Receiving Palliative Therapy

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.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Dietary supplement: Oral nutritional supplement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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; 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.; Other Names: Fortimel Compact/Fortimel Compact Fibre, Nutricia
No Intervention: Control; Patients group which takes no oral nutritional supplements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Collaborators: University Hospital Tuebingen
• Investigators: Principal Investigator: Stephan C. Bischoff, MD, Prof., Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany; Study Director: Michael Bitzer, MD; Prof., Department of Hepatology, Gastroenterology, Infectious Diseases, University Hospital Tübingen

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: November 7, 2014
• First Submitted That Met QC Criteria: December 8, 2014
• First Posted (Estimate): December 9, 2014

Study Record Updates

• Last Update Posted (Estimate): December 9, 2014
• Last Update Submitted That Met QC Criteria: December 8, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: quality of life; nutritional status; hepatocellular carcinoma; pancreatic carcinoma; oral nutritional supplements; palliative therapy
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: ZEM_Minigrad_TN