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
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'
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
To assess the efficacy of a nutritional intervention with supplementation enriched in EPA to improve the tolerance to the antineoplastic treatment, using the variation in quality of life changes as the tolerability index.
Pere Leyes, MD
Hospital Clinic of Barcelona
Spain: Ministry of Health