Fish Oil Supplement in Rectal Cancer

February 8, 2017 updated by: AC Camargo Cancer Center

Fish Oil Supplement Combined With Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01509 - 010
        • AC Camargo Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: fish oil group
4 soft gel with omega-3 fish oil
Dietary supplement: omega-3 fish oil
2,4g of EPA + DHA
No Intervention: control group
without intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 18 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 18 months
Measures: weight (kg) / Muscle mass (Kg) / adipose mass (Kg). Involuntary weight loss is common among patients with advanced cancer, contributing to poor treatment response, functional decline, and decreased survival. Nutritional intervention with fish oil may prevent deterioration of body composition.
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.
Time Frame: 18 months
Measure: hand grip strength (kg). Muscle function, assessed by hand grip strength, has been reported to be closely related to body composition and even more to muscle mass loss (sarcopenia).
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).
Time Frame: 24 months
Measured: specific oncologic questionnaire (EORTC QLQ-C30). The amount of symptoms distressed experienced by an individual has been related to QoL in a number of people with cancer. QoL is increasingly being used as a primary outcome measure in studies to evaluate the effectiveness of treatment.
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).
Time Frame: 18 months
Measures: IL-6/ IL-1 / TNF-alpha. The cytokines interleukin-6 (IL-6), tumor necrosis factor alpha (TNFalpha) and interleukin-1 beta (IL-1beta) are critical mediators of the inflammatory response. Evidence has linked elevated levels of inflammatory cytokines with both loss of weight and therapeutical response.
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.
Time Frame: 24 months
measure: pathological response grade. Pathological complete response after neoadjuvant chemoradiation and radical surgery in patients with locally advanced rectal cancer predicts better outcomes.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AC Camargo Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Samuel Aguiar Jr., PhD, AC Camargo Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1818/2013

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