Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy

NCT02779868 | Completed DMC

• 1 other identifier: 1.150.108/2015
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

body composition; functional capacity; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in Quality of life

  45 days

• Change in Quality of life

  45 days

• Change in IL-6 serum levels

  45 days

• Change in IL-1 serum levels

  45 days

• Change in TNF-alfa serum levels

  45 days

Study Arms (2)

Omega-3

EXPERIMENTAL

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

Dietary Supplement: Omega-3

Olive oil

PLACEBO COMPARATOR

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

Dietary Supplement: Olive oil

Interventions

Omega-3 DIETARY_SUPPLEMENT

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

Also known as: intervention group

Omega-3

Olive oil DIETARY_SUPPLEMENT

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

Also known as: placebo group

Olive oil

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Cervix cancer at FIGO stage II and III
• Chemoradiotherapy treatment proposal (cisplatin + radiotherapy)
• Nutritional diagnosis of pre-cachexia ou cachexia

You may not qualify if:

• metastasis (FIGO stage IV)
• Nutritional diagnosis of refractary cachexia

Sponsors & Collaborators

• Brazilian National Cancer Institute: lead

Study Sites (1)

Brazilian National Cancer Institute

Rio de Janeiro, Rio de Janeiro, 20220-410, Brazil

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Docosahexaenoic Acids; Olive Oil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mariah A Aredes, Ms

  Brazilian National Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Researcher at Brazilian National Cancer Institute

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 23, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 25, 2017

Record last verified: 2017-07

Locations

BR (1)