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

January 2, 2024 updated by: Yenny Andayani, Universitas Sriwijaya

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sumatera
      • Palembang, South Sumatera, Indonesia, 30126
        • Rumah Sakit Mohammad Hoesin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extra Virgin Olive Oil
The patients was given a capsule contained extra virgin olive oil 15 milliliters twice a day.
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
Other Names:
  • EVOO
Active Comparator: Olive Oil
The patients was given a capsule contained olive oil 15 milliliters twice a day.
Dietary supplement: Olive Oil
The patients was given olive oil.
Placebo Comparator: Placebo
The patients was given an empty capsule twice a day.
Dietary supplement: Placebo
The patients was given empty capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand Foot Syndrome
Time Frame: 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.
3 cycle of chemotherapy (63 days)
Serum COX-2 Concentration
Time Frame: 3 cycle of chemotherapy (63 days)
Serum COX-2 Concentration
3 cycle of chemotherapy (63 days)
Serum malondialdehyde concentration
Time Frame: 3 cycle of chemotherapy (63 days)
Serum malondialdehyde ceoncentration
3 cycle of chemotherapy (63 days)
Serum Tumor Necrosis Factor Alpha Concentration
Time Frame: 3 cycle of chemotherapy (63 days)
Serum Tumor Necrosis Factor Alpha Concentration
3 cycle of chemotherapy (63 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sriwijaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 20, 2024

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Estimated)

January 3, 2024

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 069/kepkrsmh/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be shared after the completion of the study and has been subjected to the consent of the individual patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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