Prevention of Cancer-associated Malnutrition Through Oral Nutritional Supplements

University of Hohenheim

Status: Unknown

Conditions: Cancer

Treatments: Dietary Supplement: Oral nutritional supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT02312674

ZEM_Minigrad_TN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intervention

Experimental group

Description:

Patient group which takes daily an adjusted amount of oral nutritional supplements through an intervention period of three months

Treatment:

Dietary Supplement: Oral nutritional supplement

Control

No Intervention group

Description:

Patients group which takes no oral nutritional supplements