Fish Oil Supplement in Rectal Cancer

NCT02534389 | Completed DMC

• 1 other identifier: 1818/2013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

rectal cancer; inflammation; omega-3; fish oil; nutritional status

Outcome Measures

Primary Outcomes (1)

• Check effects of daily consumption of 2.4 g of EPA + DHA for adults with rectal adenocarcinoma in neoadjuvant chemoradiation treatment on Glasgow Prognostic Score (GPS).

  Combination of C-reactive protein and albumin, the Glasgow Prognostic Score (GPS), had independent prognostic value in patients with cancer. The GPS is the most extensively validated of the systemic inflammation-based prognostic scores and may be used in the routine clinical assessment of patients with cancer.

  18 months

Secondary Outcomes (5)

• Check effects of daily consumption of 2.4 g of EPA + DHA for adults with rectal adenocarcinoma in neoadjuvant chemoradiation treatment on body weight and body composition with regard to skeletal muscle mass, and adipose tissue.

  18 months

• Check for effects of daily consumption of 2.4 g of EPA + DHA for adults with rectal adenocarcinoma in neoadjuvant chemoradiation treatment on muscle function.

  18 months

• Check for effects of daily consumption of 2.4 g of EPA + DHA for adults with rectal adenocarcinoma in neoadjuvant chemoradiation treatment on quality of life (QOL).

  24 months

• Check for effects of daily consumption of 2.4 g of EPA + DHA for adults with rectal adenocarcinoma in neoadjuvant chemoradiation treatment on inflammatory cytokines (IL-6, IL-1, TNF-alpha).

  18 months

• Check for effects of daily consumption of 2.4 g of EPA + DHA for adults with rectal adenocarcinoma in neoadjuvant chemoradiation treatment on pathological response.

  24 months

Study Arms (2)

fish oil group

EXPERIMENTAL

4 soft gel with omega-3 fish oil

Dietary Supplement: omega-3 fish oil

control group

NO INTERVENTION

without intervention

Interventions

omega-3 fish oil DIETARY_SUPPLEMENT

2,4g of EPA + DHA

fish oil group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AC Camargo Cancer Center: lead
• University of Sao Paulo: collaborator

Study Sites (1)

AC Camargo Cancer Center

São Paulo, São Paulo, 01509 - 010, Brazil

Location

MeSH Terms

Conditions

Rectal Neoplasms; Inflammation

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Samuel Aguiar Jr., PhD

  AC Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 27, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: February 1, 2017
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

BR (1)