Sarcopenia
Conditions
Keywords
body composition, functional capacity, quality of life
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.
Interventions
DIETARY_SUPPLEMENTOmega-3
patients included in this group will take 2g (4 capsules) per day of eicosapentaenoic acid.
DIETARY_SUPPLEMENTOlive oil
patients included in this group will take 4 capsules per day of olive oil.
Sponsors
Brazilian National Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 Quality of life | 45 days | Change in quality of life assessed by EORCT QL30 questionaire before and at the end of chemotherapy treatment (45 day after the first chemotherapy) |
| Change in handgrip strength | 45 days | change in handgrip strength before and at the end of chemotherapy treatment (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 |
| 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) |
Countries
Brazil
Outcome results
None listed