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

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Dietary supplement: Eicosapentaenoic acid enriched nutritional supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clinic of Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Eicosapentaenoic acid enriched nutritional supplement	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.; Other Names: Prosure
NO_INTERVENTION: No supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the influence of the nutritional status over the tolerance to the antineoplastic treatment.	6 months
To assess the effect of a nutritional supplement over the nutritional status of the patient with disseminated neoplastic illness.	3 months

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Abbott
• Investigators: Principal Investigator: Pere Leyes, MD, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• Trabal J, Leyes P, Forga M, Maurel J. Potential usefulness of an EPA-enriched nutritional supplement on chemotherapy tolerability in cancer patients without overt malnutrition. Nutr Hosp. 2010 Sep-Oct;25(5):736-40.

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (ACTUAL): March 1, 2008
• Study Completion (ACTUAL): March 1, 2008

Study Registration Dates

• First Submitted: November 9, 2006
• First Submitted That Met QC Criteria: November 9, 2006
• First Posted (ESTIMATE): November 10, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): June 20, 2013
• Last Update Submitted That Met QC Criteria: June 19, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Quality of Life; Colorectal Neoplasms; Nutritional Status; Eicosapentaenoic Acid
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: EPA-05; EPA-05/ ACA-SPAI-05-05 (OTHER: Hospital Clinic de Barcelona's Ethics Committee)