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Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors

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Charité University Medicine Berlin

Status and phase

Completed
Phase 4

Conditions

Hepatocellular Carcinoma
Cholangiocarcinoma
Colorectal Neoplasms

Treatments

Drug: oral nutritional supplement rich in eicosapentanoic acid

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00168987
EA1/174/05

Details and patient eligibility

About

Malnutrition is a frequent symptom of various malignant diseases and is frequently observed in patients with gastrointestinal tumors. Eicosapentanoic acid (EPA) has been introduced as specific and anticatabolic acting substrate in cancer patients. Only few randomized trials are available which investigated the effect of EPA in form of an EPA-enriched, protein- and energy-dense oral nutritional supplement mostly in patients with pancreatic carcinoma.

Therefore, the effect of an EPA-rich oral nutritional supplement for two months on functional state and quality of life in patients with other gastroenterological tumors and weight loss is investigated in this randomized prospective trial.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • malignant disease: colorectal neoplasm, hepatocellular carcinoma, cholangiocarcinoma
  • palliative treatment of malignant disease: UICC stage >1
  • impaired nutritional state: weight loss > 5% body weight in the preceding 6 months or subjective global assessment grade B (moderately malnourished) or grade C (severely malnourished)
  • informed written consent

Exclusion criteria

  • age < 18 years
  • pregnancy
  • exclusive enteral or parenteral nutrition
  • taking of eicosapentanoic acid in form of fish oil capsules
  • contraindications for oral nutrition (i.e. ileus, uncontrollable vomiting)
  • terminal stage of disease with a life expectancy < 3 months
  • missing or withdrawn consent
  • simultaneous participation in another trial

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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