Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy

Brazilian National Cancer Institute

Status: Completed

Conditions: Sarcopenia

Treatments: Dietary Supplement: Omega-3; Dietary Supplement: Olive oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02779868

1.150.108/2015

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 20 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Omega-3

Experimental group

Description:

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

Treatment:

Dietary Supplement: Omega-3

Olive oil

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Olive oil