Clinical trial NCT00398333: Study to Assess the Effectiveness of a Omega-3 Enriched Supplement on Chemotherapy Tolerance in Colon Cancer Patients
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Colorectal Neoplasms
Keywords: Colorectal Neoplasms
Eicosapentaenoic Acid
Quality of Life
Nutritional Status
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2006-11-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: 3 months
Secondary outcomes:
measure: To assess the influence of the nutritional status over the tolerance to the antineoplastic treatment.
timeFrame: 6 months
measure: To assess the effect of a nutritional supplement over the nutritional status of the patient with disseminated neoplastic illness.
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
state: Catalonia
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Pere Leyes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.