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

This study has been terminated.
(Impossibility to accomplish the sample size in assigned time.)
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Pere Leyes, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00398333
First received: November 9, 2006
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Colorectal Neoplasms
Dietary Supplement: Eicosapentaenoic acid enriched nutritional supplement
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the influence of the nutritional status over the tolerance to the antineoplastic treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the effect of a nutritional supplement over the nutritional status of the patient with disseminated neoplastic illness. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: June 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398333

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

Publications:
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
Study First Received: November 9, 2006
Last Updated: June 19, 2013
Health Authority: Spain: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 19, 2014