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

June 19, 2013 updated by: Pere Leyes, Hospital Clinic of Barcelona

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Abbott

Investigators

  • Principal Investigator: Pere Leyes, MD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPA-05
  • EPA-05/ ACA-SPAI-05-05 (OTHER: Hospital Clinic de Barcelona's Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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