Ignite Creation Date:
2024-05-06 @ 7:26 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02534389
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2015-08-17
Brief Title:
Fish Oil Supplement in Rectal Cancer
Sponsor:
AC Camargo Cancer Center
Organization:
AC Camargo Cancer Center
Study Overview
Official Title:
Fish Oil Supplement Combined With Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neoadjuvant treatment with radiotherapy RDT and chemotherapy CT are the treatment of choice for rectal adenocarcinomas in stages II and III This results currently in pathologic complete response in 10 to 30 of cases The immune and inflammatory response is altered in these individuals and is directly related to response to therapy Both the disease and the treatment of colorectal cancer have an impact on quality of life and nutritional status In studies with cells and animal models the incorporation of fatty acids eicosapentaenoic acid EPA and docosahexaenoic DHA - derived from fish oil - has been shown to interfere in the process of inflammation cell signaling and gene transcription enhancing the response to treatment Are reported ability to restore the apoptosis of tumor cells sensitization of tumor cells to chemotherapy production of less pro-inflammatory cytokines and the preservation of normal energy and protein metabolism The aim of this study is to verify if the daily consumption of 24 g EPA DHA for adults in neoadjuvant therapy can promote changes on inflammatory and immunological markers of host response to tumor and if this response is altered by nutritional status It is expected that supplementation can reflect in control of inflammatory and immune response in favor of tumor cell death contributes to pathological complete response and that it happens with preservation of nutritional status Subjects will be randomized as to supplementation All will be assessed in four moments during neoadjuvant therapy and immediate postoperative Results will be presented by comparing the intervention group and control group at each moment
Detailed Description:
None
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