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Prevention of Cancer-associated Malnutrition Through Oral Nutritional Supplements

NCT ID: NCT02312674

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-01-31

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.

Conditions

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Cancer

Keywords

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pancreatic carcinoma hepatocellular carcinoma palliative therapy oral nutritional supplements quality of life nutritional status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Oral nutritional supplement

Intervention Type DIETARY_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.

Control

Patients group which takes no oral nutritional supplements

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Fortimel Compact/Fortimel Compact Fibre, Nutricia

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role collaborator

University of Hohenheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan C. Bischoff, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany

Michael Bitzer, MD; Prof.

Role: STUDY_DIRECTOR

Department of Hepatology, Gastroenterology, Infectious Diseases, University Hospital Tübingen

Central Contacts

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Stephan C. Bischoff, MD, Prof.

Role: CONTACT

Phone: 0049 711 45924101

Email: [email protected]

Janna Jayme

Role: CONTACT

Email: [email protected]

Other Identifiers

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ZEM_Minigrad_TN

Identifier Type: -

Identifier Source: org_study_id