Fish Oil Supplement in Rectal Cancer

NCT ID: NCT02534389

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-02-28

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 2.4 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.

Conditions

Rectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fish oil group

4 soft gel with omega-3 fish oil

Group Type: EXPERIMENTAL

omega-3 fish oil

Intervention Type: DIETARY_SUPPLEMENT

2,4g of EPA + DHA

control group

without intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

omega-3 fish oil

2,4g of EPA + DHA

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Candidate to neoadjuvant therapy according AC Camargo Cancer Center protocol;
• Accept consume fish oil capsules and participate in clinical, pathological and nutritional assessments by signing the consent form.

Exclusion Criteria

• Be allergic to fish and fish products,
• It has previously undergone treatment for colorectal cancer or in presence of other concomitant cancer treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

AC Camargo Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Aguiar Jr., PhD

Role: PRINCIPAL_INVESTIGATOR

AC Camargo Cancer Center

Locations

AC Camargo Cancer Center

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

1818/2013

Identifier Type: -

Identifier Source: org_study_id