Status:
TERMINATED
Study to Assess the Effectiveness of a Omega-3 Enriched Supplement on Chemotherapy Tolerance in Colon Cancer Patients
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Abbott
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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%. Un...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00398333
Start Date
June 1 2005
End Date
March 1 2008
Last Update
June 20 2013
Active Locations (1)
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1
Hospital Clinic of Barcelona
Barcelona, Catalonia, Spain, 08036