Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779868
• Other study ID #: 1.150.108/2015
• Status: Completed
• Phase: N/A
• First received: May 17, 2016
• Last updated: July 24, 2017
• Start date: May 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Brazilian National Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia
• Uterine Cervical Neoplasms

Intervention

Dietary Supplement:
• Omega-3
patients included in this group will take 2g (4 capsules) per day of eicosapentaenoic acid.
• Olive oil
patients included in this group will take 4 capsules per day of olive oil.

Locations

Country	Name	City	State
Brazil	Brazilian National Cancer Institute	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Brazilian National Cancer Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in handgrip strength	change in handgrip strength before and at the end of chemotherapy treatment (45 days)	45 days
Secondary	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
Secondary	chemoradiotherapy toxicity	chemoradiotherapy will be assessed by Chemotherapy toxicity criteria (CTC) version 4.0	15 and 45 days