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
18 Years
N/A
Both
Colorectal Neoplasms
Trial Information
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'
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.
Inclusion Criteria:
- Patients diagnosed of metastatic colon adenocarcinoma that are going to receive first
line chemotherapy treatment in the oncology day hospital.
- Age over 18 years old.
Exclusion Criteria:
- Patients diagnosed of colon cancer are receiving second line chemotherapy.
- Antecedents of other malignant tumors with the exception of basocellular epithelioma.
- Chronic renal failure (Creatinine > 1.7).
- Previous diabetes mellitus.
- Obesity (IMC > 30)
- Medical conditions that imply hepatic encephalopathy, or ascites.
- Severe malnutrition according to the classification of the Subjective Global
Assessment (SGA) or a BMI < 16.5.
- Major psychiatric disorder.
- Patients receiving enteral or parenteral nutrition.
- Contraindications for the indication of the nutritional supplement: Galactosemia.
- Seafood or seafood byproducts allergy.
- Patients taking drugs that affect the metabolism (anabolic steroids, orexigenic
agents...).
- Absence of the informed consent form signed by the patient.
- Any patient who has disability to comply with the treatment or who has inability
according to the researcher.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
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.
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Pere Leyes, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospital Clinic of Barcelona
Authority:
Spain: Ministry of Health
Study ID:
EPA-05
NCT ID:
NCT00398333
Start Date:
June 2005
Completion Date:
March 2008
Related Keywords:
- Colorectal Neoplasms
- Colorectal Neoplasms
- Eicosapentaenoic Acid
- Quality of Life
- Nutritional Status
- Neoplasms
- Colorectal Neoplasms
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