Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy

Effect of Omega-3 Supplementation on Body Composition, Functional Capacity, Inflammatory Profile and Quality of Life in Cervix Cancer Patients Undergoing Chemoradiotherapy

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Omega-3; Dietary supplement: Olive oil

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20220-410
      • Brazilian National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 59 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Omega-3; Group who will receive 2g eicosapentaenoic (4 capsules) acid per day during the chemoradiotherapy protocol.	Dietary supplement: Omega-3; patients included in this group will take 2g (4 capsules) per day of eicosapentaenoic acid.; Other Names: intervention group
PLACEBO_COMPARATOR: Olive oil; Group who will receive olive oil per day (4 capsules) during the chemoradiotherapy protocol.	Dietary supplement: Olive oil; patients included in this group will take 4 capsules per day of olive oil.; Other Names: placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	45 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	45 days
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)	45 days
Change in IL-6 serum levels	Change in serum levels of IL-6 (ng/mL) before and at the end of chemotherapy (45 days)	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)	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)	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)	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)	45 days
Change in handgrip strength	change in handgrip strength before and at the end of chemotherapy treatment (45 days)	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)	45 days
chemoradiotherapy toxicity	chemoradiotherapy will be assessed by Chemotherapy toxicity criteria (CTC) version 4.0	15 and 45 days

Collaborators and Investigators

• Sponsor: Brazilian National Cancer Institute
• Investigators: Study Chair: Mariah A Aredes, Ms, Brazilian National Cancer Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 20, 2016
• First Posted (ESTIMATE): May 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: quality of life; body composition; functional capacity
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neurologic Manifestations; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Uterine Cervical Neoplasms; Sarcopenia
• Other Study ID Numbers: 1.150.108/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED