Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy

NCT ID: NCT02779868

Last Updated: 2017-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-07-31

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.

Detailed Description

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Omega-3

Group who will receive 2g eicosapentaenoic (4 capsules) acid per day during the chemoradiotherapy protocol.

Group Type EXPERIMENTAL

Omega-3

Intervention Type DIETARY_SUPPLEMENT

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

Olive oil

Group who will receive olive oil per day (4 capsules) during the chemoradiotherapy protocol.

Group Type PLACEBO_COMPARATOR

Olive oil

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Omega-3

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

Intervention Type DIETARY_SUPPLEMENT

Olive oil

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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intervention group placebo group

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Brazilian National Cancer Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gabriela Villaça Chaves

PhD, Researcher at Brazilian National Cancer Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariah A Aredes, Ms

Role: STUDY_CHAIR

Brazilian National Cancer Institute

Locations

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Brazilian National Cancer Institute

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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1.150.108/2015

Identifier Type: -

Identifier Source: org_study_id

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