Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Omega-3
* Dietary Supplement: Olive oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3<br>Group who will receive 2g eicosapentaenoic (4 capsules) acid per day during the chemoradiotherapy protocol. | Dietary Supplement: Omega-3<br>* patients included in this group will take 2g (4 capsules) per day of eicosapentaenoic acid.<br>* Other names: intervention group;|
| Placebo Comparator: Olive oil<br>Group who will receive olive oil per day (4 capsules) during the chemoradiotherapy protocol. | Dietary Supplement: Olive oil<br>* patients included in this group will take 4 capsules per day of olive oil.<br>* Other names: placebo group;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, body composition, functional capacity