NCT00398333

Study to Assess the Effectiveness of a Omega-3 Enriched Supplement on Chemotherapy Tolerance in Colon Cancer Patients

Randomized Controlled, Open-label, Pilot Study to Assess the Effectiveness of a Nutritional Supplementation Enriched With Eicosapentaenoic Acid on Chemotherapy Tolerance in Patients With Advanced Colorectal Cancer

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if a nutritional supplement enriched in omega-3 fatty acids is effective in improving the tolerance to chemotherapy treatment and improves quality of life.

Detailed description

Colorectal cancer is one of the main causes of mortality in western countries. It is considered that in case of colorectal carcinoma, the frequency of weight loss at the moment of diagnosis is 54%. Undernourishment affects negatively the course of the illness and it confers a worse prognostic, increasing the morbidity and the mortality, while it entails an impairment in the quality of life of the patient. There is a narrow relationship in the oncologic pathology between undernourishment and the pathology itself, drawing a common syndrome called cancerous cachexia. It is usual that patients subjected to chemotherapy present nutritional alterations due to the treatments' side effects. With this study we want to assess the efficacy of a nutritional intervention with supplementation enriched in EPA to improve the tolerance to the antineoplastic treatment. As an index of tolerability to the chemotherapy treatment, it will be used the variation of changes in quality of life evaluated through the questionnaire EORTC QLQ-C30, using the parameters of global quality of life and physical function.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Eicosapentaenoic acid enriched nutritional supplement	Oral intake of nutritional supplementation: a maximum of 480 mL or a minimum of 240 mL daily during the first 3 months of the study.

Timeline

• Start date: 2005-06-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2006-11-10
• Last updated: 2013-06-20

Locations

1 site across 1 country: Spain