Study to Assess the Effectiveness of a Omega-3 Enriched Supplement on Chemotherapy Tolerance in Colon Cancer Patients
|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
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Dietary Supplement: Eicosapentaenoic acid enriched nutritional supplement||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|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|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
|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|
- 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 ]
- To assess the influence of the nutritional status over the tolerance to the antineoplastic treatment. [ Time Frame: 6 months ]
- To assess the effect of a nutritional supplement over the nutritional status of the patient with disseminated neoplastic illness. [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398333
|Hospital Clinic of Barcelona|
|Barcelona, Catalonia, Spain, 08036|
|Principal Investigator:||Pere Leyes, MD||Hospital Clinic of Barcelona|