NCT06188000

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

Efficacy of Extra Virgin Olive Oil (EVOO) Supplementation on Serum COX-2, Malondialdehyde, TNF-alpha, and Hand-Foot Syndrome Incidence in Patients With Capecitabine

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Universitas Sriwijaya · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hand and Foot Skin Reaction
• Hand and Foot Syndrome
• Capecitabine

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Extra Virgin Olive Oil	The patients was given extra virgin olive oil, an unrefined (not processed with chemicals or heat) for of olive oil
DIETARY_SUPPLEMENT	Olive Oil	The patients was given olive oil.
DIETARY_SUPPLEMENT	Placebo	The patients was given empty capsule

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-02-01
• Completion: 2024-02-20
• First posted: 2024-01-03
• Last updated: 2024-01-03

Locations

1 site across 1 country: Indonesia