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Fish Oil Supplement in Rectal Cancer

Primary Purpose

Rectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
omega-3 fish oil
Sponsored by
AC Camargo Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring rectal cancer, inflammation, omega-3, fish oil, nutritional status

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AC Camargo Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

fish oil group

control group

Arm Description

4 soft gel with omega-3 fish oil

without intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).
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).
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.
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).
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.
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.
measure: pathological response grade. Pathological complete response after neoadjuvant chemoradiation and radical surgery in patients with locally advanced rectal cancer predicts better outcomes.

Full Information

First Posted
August 17, 2015
Last Updated
February 8, 2017
Sponsor
AC Camargo Cancer Center
Collaborators
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02534389
Brief Title
Fish Oil Supplement in Rectal Cancer
Official Title
Fish Oil Supplement Combined With Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AC Camargo Cancer Center
Collaborators
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
rectal cancer, inflammation, omega-3, fish oil, nutritional status

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fish oil group
Arm Type
Experimental
Arm Description
4 soft gel with omega-3 fish oil
Arm Title
control group
Arm Type
No Intervention
Arm Description
without intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3 fish oil
Intervention Description
2,4g of EPA + DHA
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
18 months
Title
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.
Description
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).
Time Frame
18 months
Title
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).
Description
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.
Time Frame
24 months
Title
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).
Description
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.
Time Frame
18 months
Title
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.
Description
measure: pathological response grade. Pathological complete response after neoadjuvant chemoradiation and radical surgery in patients with locally advanced rectal cancer predicts better outcomes.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Aguiar Jr., PhD
Organizational Affiliation
AC Camargo Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
AC Camargo Cancer Center
City
São Paulo
ZIP/Postal Code
01509 - 010
Country
Brazil

12. IPD Sharing Statement

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Fish Oil Supplement in Rectal Cancer

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