Prevention of Cancer-associated Malnutrition Through Oral Nutritional Supplements

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Dietary Supplement: Oral nutritional supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patient group which takes daily an adjusted amount of oral nutritional supplements through an intervention period of three months | Dietary Supplement: Oral nutritional supplement<br>* 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.<br>* Other names: Fortimel Compact/Fortimel Compact Fibre, Nutricia;|
| No Intervention: Control<br>Patients group which takes no oral nutritional supplements | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic carcinoma, hepatocellular carcinoma, palliative therapy, oral nutritional supplements, quality of life, nutritional status