Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398333
Status:
TERMINATED
Last Update Posted:
2013-06-20
First Post:
2006-11-09
Brief Title:
Study to Assess the Effectiveness of a Omega-3 Enriched Supplement on Chemotherapy Tolerance in Colon Cancer Patients
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Impossibility to accomplish the sample size in assigned time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EPA-05 ACA-SPAI-05-05 | OTHER | Hospital Clinic de Barcelonas Ethics Committee | None |