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

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00398333
• Other study ID #: EPA-05
• Secondary ID: EPA-05/ ACA-SPAI
• Status: Terminated
• Phase: Phase 4
• First received: November 9, 2006
• Last updated: June 19, 2013
• Start date: June 2005
• Est. completion date: March 2008

Study information

• Verified date: June 2013
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Abbott

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess the influence of the nutritional status over the tolerance to the antineoplastic treatment.		6 months	No
Secondary	To assess the effect of a nutritional supplement over the nutritional status of the patient with disseminated neoplastic illness.		3 months	No