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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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