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NCT Number: NCT02779868

Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy

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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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brazilian National Cancer Institute

Rio de Janeiro, 20220-410, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3

Dietary Supplement

patients included in this group will take 2g (4 capsules) per day of eicosapentaenoic acid.

Other names: intervention group

Olive Oil

Dietary Supplement

patients included in this group will take 4 capsules per day of olive oil.

Other names: placebo group

Primary outcomes

  1. Change in Body composition

    Time frame: 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 outcomes

  1. Change in Quality of life

    Time frame: 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)

  2. Change in Quality of life

    Time frame: 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)

  3. Change in IL-6 serum levels

    Time frame: 45 days

    Change in serum levels of IL-6 (ng/mL) before and at the end of chemotherapy (45 days)

  4. Change in IL-1 serum levels

    Time frame: 45 days

    Change in serum levels of IL-1 (ng/mL) before and at the end of chemotherapy (45 days)

  5. Change in TNF-alfa serum levels

    Time frame: 45 days

    Change in serum levels of TNF-alfa (ng/mL) before and at the end of chemotherapy (45 days)

  6. Change in INF-gama serum levels

    Time frame: 45 days

    Change in serum levels of INF-gama (ng/mL) before and at the end of chemotherapy (45 days)

  7. Change in membrane incorporation of non-esterified fatty acids

    Time frame: 45 days

    Change in membrane incorporation of non-esterified fatty acids assessed by Gas chromatography of fatty acid methyl esters (nmol/mL)

  8. Change in handgrip strength

    Time frame: 45 days

    change in handgrip strength before and at the end of chemotherapy treatment (45 days)

  9. Change in functional capacity (30 second stand chair test)

    Time frame: 45 days

    change in functional capacity assessed by 30 second stand chair test before and at the end of chemotherapy treatment (45 days)

  10. chemoradiotherapy toxicity

    Time frame: 15 and 45 days

    chemoradiotherapy will be assessed by Chemotherapy toxicity criteria (CTC) version 4.0

Sponsors and collaborators

Lead sponsor

Brazilian National Cancer Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 23, 2016
Registry last updated
Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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