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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 | Experimental | Group who will receive 2g eicosapentaenoic (4 capsules) acid per day during the chemoradiotherapy protocol. |
|
| Olive oil | Placebo Comparator | Group who will receive olive oil per day (4 capsules) during the chemoradiotherapy protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 | Dietary Supplement | patients included in this group will take 2g (4 capsules) per day of eicosapentaenoic acid. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariah A Aredes, Ms | Brazilian National Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brazilian National Cancer Institute | Rio de Janeiro | Rio de Janeiro | 20220-410 | Brazil |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Olive oil | Dietary Supplement | patients included in this group will take 4 capsules per day of olive oil. |
|
|
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 |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |