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Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Omega-3
Olive oil
Sponsored by
Brazilian National Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring body composition, functional capacity, quality of life

Eligibility Criteria

20 Years - 59 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Cervix cancer at FIGO stage II and III
  • Chemoradiotherapy treatment proposal (cisplatin + radiotherapy)
  • Nutritional diagnosis of pre-cachexia ou cachexia

Exclusion Criteria:

  • metastasis (FIGO stage IV)
  • Nutritional diagnosis of refractary cachexia

Sites / Locations

  • Brazilian National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omega-3

Olive oil

Arm Description

Group who will receive 2g eicosapentaenoic (4 capsules) acid per day during the chemoradiotherapy protocol.

Group who will receive olive oil per day (4 capsules) during the chemoradiotherapy protocol.

Outcomes

Primary Outcome Measures

Change in Body composition
Change from baseline body composition assessed by computed tomography scans before and at the end of chemotherapy treatment (45 day after the first chemotherapy)

Secondary Outcome Measures

Change in Quality of life
Change in quality of life assessed by EORCT QL30 questionaire before and at the end of chemotherapy treatment (45 day after the first chemotherapy)
Change in Quality of life
Change in quality of life assessed by and EQ-5D-3L questionaire before and at the end of chemotherapy treatment (45 day after the first chemotherapy)
Change in IL-6 serum levels
Change in serum levels of IL-6 (ng/mL) before and at the end of chemotherapy (45 days)
Change in IL-1 serum levels
Change in serum levels of IL-1 (ng/mL) before and at the end of chemotherapy (45 days)
Change in TNF-alfa serum levels
Change in serum levels of TNF-alfa (ng/mL) before and at the end of chemotherapy (45 days)
Change in INF-gama serum levels
Change in serum levels of INF-gama (ng/mL) before and at the end of chemotherapy (45 days)
Change in membrane incorporation of non-esterified fatty acids
Change in membrane incorporation of non-esterified fatty acids assessed by Gas chromatography of fatty acid methyl esters (nmol/mL)
Change in handgrip strength
change in handgrip strength before and at the end of chemotherapy treatment (45 days)
Change in functional capacity (30 second stand chair test)
change in functional capacity assessed by 30 second stand chair test before and at the end of chemotherapy treatment (45 days)
chemoradiotherapy toxicity
chemoradiotherapy will be assessed by Chemotherapy toxicity criteria (CTC) version 4.0

Full Information

First Posted
May 17, 2016
Last Updated
July 24, 2017
Sponsor
Brazilian National Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02779868
Brief Title
Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy
Official Title
Effect of Omega-3 Supplementation on Body Composition, Functional Capacity, Inflammatory Profile and Quality of Life in Cervix Cancer Patients Undergoing Chemoradiotherapy
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brazilian National Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by cachexia. Recently, omega-3 fatty acids have gained interest for their beneficial effects in cancer cachexia. Moreover, nutritional supplementation enriched with omega-3 could potentially maintain body weight in cancer patients undergoing intensive treatment. The investigators aims in this study is to evaluate the effect of omega-3 supplementation on body composition, functional capacity, inflammatory profile and quality of life in cervix cancer patients undergoing chemoradiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
body composition, functional capacity, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3
Arm Type
Experimental
Arm Description
Group who will receive 2g eicosapentaenoic (4 capsules) acid per day during the chemoradiotherapy protocol.
Arm Title
Olive oil
Arm Type
Placebo Comparator
Arm Description
Group who will receive olive oil per day (4 capsules) during the chemoradiotherapy protocol.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Other Intervention Name(s)
intervention group
Intervention Description
patients included in this group will take 2g (4 capsules) per day of eicosapentaenoic acid.
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive oil
Other Intervention Name(s)
placebo group
Intervention Description
patients included in this group will take 4 capsules per day of olive oil.
Primary Outcome Measure Information:
Title
Change in Body composition
Description
Change from baseline body composition assessed by computed tomography scans before and at the end of chemotherapy treatment (45 day after the first chemotherapy)
Time Frame
45 days
Secondary Outcome Measure Information:
Title
Change in Quality of life
Description
Change in quality of life assessed by EORCT QL30 questionaire before and at the end of chemotherapy treatment (45 day after the first chemotherapy)
Time Frame
45 days
Title
Change in Quality of life
Description
Change in quality of life assessed by and EQ-5D-3L questionaire before and at the end of chemotherapy treatment (45 day after the first chemotherapy)
Time Frame
45 days
Title
Change in IL-6 serum levels
Description
Change in serum levels of IL-6 (ng/mL) before and at the end of chemotherapy (45 days)
Time Frame
45 days
Title
Change in IL-1 serum levels
Description
Change in serum levels of IL-1 (ng/mL) before and at the end of chemotherapy (45 days)
Time Frame
45 days
Title
Change in TNF-alfa serum levels
Description
Change in serum levels of TNF-alfa (ng/mL) before and at the end of chemotherapy (45 days)
Time Frame
45 days
Title
Change in INF-gama serum levels
Description
Change in serum levels of INF-gama (ng/mL) before and at the end of chemotherapy (45 days)
Time Frame
45 days
Title
Change in membrane incorporation of non-esterified fatty acids
Description
Change in membrane incorporation of non-esterified fatty acids assessed by Gas chromatography of fatty acid methyl esters (nmol/mL)
Time Frame
45 days
Title
Change in handgrip strength
Description
change in handgrip strength before and at the end of chemotherapy treatment (45 days)
Time Frame
45 days
Title
Change in functional capacity (30 second stand chair test)
Description
change in functional capacity assessed by 30 second stand chair test before and at the end of chemotherapy treatment (45 days)
Time Frame
45 days
Title
chemoradiotherapy toxicity
Description
chemoradiotherapy will be assessed by Chemotherapy toxicity criteria (CTC) version 4.0
Time Frame
15 and 45 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cervix cancer at FIGO stage II and III Chemoradiotherapy treatment proposal (cisplatin + radiotherapy) Nutritional diagnosis of pre-cachexia ou cachexia Exclusion Criteria: metastasis (FIGO stage IV) Nutritional diagnosis of refractary cachexia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariah A Aredes, Ms
Organizational Affiliation
Brazilian National Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Brazilian National Cancer Institute
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20220-410
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy

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