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

Not Applicable

Active, not recruiting

• Conditions: Hand and Foot Skin Reaction; Capecitabine; Hand and Foot Syndrome
• Interventions: Dietary Supplement: Extra Virgin Olive Oil; Dietary Supplement: Olive Oil; Dietary Supplement: Placebo

• Registration Number: NCT06188000
• Lead Sponsor: Universitas Sriwijaya

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-03-14
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-02
• Last Update Submitted: 2024-01-02
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extra Virgin Olive Oil	Extra Virgin Olive Oil	The patients was given a capsule contained extra virgin olive oil 15 milliliters twice a day.
Olive Oil	Olive Oil	The patients was given a capsule contained olive oil 15 milliliters twice a day.
Placebo	Placebo	The patients was given an empty capsule twice a day.

Primary Outcome Measures

Name	Time	Method
Serum COX-2 Concentration	3 cycle of chemotherapy (63 days)	Serum COX-2 Concentration
Hand Foot Syndrome	3 cycle of chemotherapy (63 days)	Patients was documented for hand and foot syndrome using WHO criteria. There were 4 grade assessed by patient symptoms of tingling or burning or painful sensation, palmar or plantar erythema or desquamation, and/or ulceration.
Serum Tumor Necrosis Factor Alpha Concentration	3 cycle of chemotherapy (63 days)	Serum Tumor Necrosis Factor Alpha Concentration
Serum malondialdehyde concentration	3 cycle of chemotherapy (63 days)	Serum malondialdehyde ceoncentration

Trial Locations

Locations (1)

Rumah Sakit Mohammad Hoesin; 🇮🇩 Palembang, South Sumatera, Indonesia