Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy

Not Applicable

Completed

• Conditions: Sarcopenia
• Interventions: Dietary Supplement: Omega-3; Dietary Supplement: Olive oil

• Registration Number: NCT02779868
• Lead Sponsor: Brazilian National Cancer Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-23
• Status Verified: 2017-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega-3	Omega-3	Group who will receive 2g eicosapentaenoic (4 capsules) acid per day during the chemoradiotherapy protocol.
Olive oil	Olive oil	Group who will receive olive oil per day (4 capsules) during the chemoradiotherapy protocol.

Primary Outcome Measures

Name	Time	Method
Change in Body composition	45 days	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

Name	Time	Method
Change in Quality of life	45 days	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 INF-gama serum levels	45 days	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	45 days	Change in membrane incorporation of non-esterified fatty acids assessed by Gas chromatography of fatty acid methyl esters (nmol/mL)
Change in handgrip strength	45 days	change in handgrip strength before and at the end of chemotherapy treatment (45 days)
Change in IL-6 serum levels	45 days	Change in serum levels of IL-6 (ng/mL) before and at the end of chemotherapy (45 days)
Change in IL-1 serum levels	45 days	Change in serum levels of IL-1 (ng/mL) before and at the end of chemotherapy (45 days)
Change in TNF-alfa serum levels	45 days	Change in serum levels of TNF-alfa (ng/mL) before and at the end of chemotherapy (45 days)
Change in functional capacity (30 second stand chair test)	45 days	change in functional capacity assessed by 30 second stand chair test before and at the end of chemotherapy treatment (45 days)
chemoradiotherapy toxicity	15 and 45 days	chemoradiotherapy will be assessed by Chemotherapy toxicity criteria (CTC) version 4.0

Trial Locations

Locations (1)

Brazilian National Cancer Institute; 🇧🇷 Rio de Janeiro, RJ, Brazil