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

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ClinicalTrials.gov Identifier: NCT00398333
Recruitment Status : Terminated (Impossibility to accomplish the sample size in assigned time.)
First Posted : November 10, 2006
Last Update Posted : June 20, 2013
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Dietary Supplement: Eicosapentaenoic acid enriched nutritional supplement Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : June 2005
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: Prosure
No Intervention: No supplementation

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398333

Hospital Clinic of Barcelona
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Principal Investigator: Pere Leyes, MD Hospital Clinic of Barcelona
More Information

Responsible Party: Pere Leyes, Specialist, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00398333     History of Changes
Other Study ID Numbers: EPA-05
EPA-05/ ACA-SPAI-05-05 ( Other Identifier: Hospital Clinic de Barcelona's Ethics Committee )
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: June 2013

Keywords provided by Pere Leyes, Hospital Clinic of Barcelona:
Colorectal Neoplasms
Eicosapentaenoic Acid
Quality of Life
Nutritional Status

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases