Efficacy of Extra Virgin Olive Oil (EVOO) Supplementation on Hand-Foot Syndrome Incidence in Patients With Capecitabine

Universitas Sriwijaya

Status: Active, not recruiting

Conditions: Hand and Foot Syndrome; Capecitabine; Hand and Foot Skin Reaction

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Extra Virgin Olive Oil; Dietary Supplement: Olive Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06188000

069/kepkrsmh/2022

Details and patient eligibility

About

The study was aimed to evaluate the efficacy of extra virgin olive oil (EVOO) supplementation compared to placebo to prevent HFS by observing changes in serum COX 2, malondialdehyde (MDA), and TNF α levels in breast cancer and colorectal cancer patients undergoing capecitabine chemotherapy. Current study was designed as a single-center prospective randomized clinical trial. The patients were Stage III or Stage IV colorectal and breast cancer patients receiving capecitabine-based chemotherapy who enrolled in the trial voluntarily. All patients were divided randomly into three groups treated with EVOO, olive oil, or placebo. The incidence of hand foot syndrome was documented. The serum COX 2, malondialdehyde (MDA), and TNF α levels before and after chemotherapy was documented.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients pathologically and clinically diagnosed with III or IV stadium of breast cancer or colorectal cancer.
• fully recovered after curative resection within 8 weeks
• receive adjuvant capecitabine based chemotherapy

Exclusion criteria

• did not meet the eligibility criteria for chemotherapy
• had previous allergy with capecitabine or olive oil

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Extra Virgin Olive Oil

Experimental group

Description:

The patients was given a capsule contained extra virgin olive oil 15 milliliters twice a day.

Treatment:

Dietary Supplement: Extra Virgin Olive Oil

Olive Oil

Active Comparator group

Description:

The patients was given a capsule contained olive oil 15 milliliters twice a day.

Treatment:

Dietary Supplement: Olive Oil

Placebo

Placebo Comparator group

Description:

The patients was given an empty capsule twice a day.

Treatment:

Dietary Supplement: Placebo