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

NCT06188000 | Unknown

• 1 other identifier: 069/kepkrsmh/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Hand Foot Syndrome

  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

  Serum COX-2 Concentration

  3 cycle of chemotherapy (63 days)

• Serum malondialdehyde concentration

  Serum malondialdehyde ceoncentration

  3 cycle of chemotherapy (63 days)

• Serum Tumor Necrosis Factor Alpha Concentration

  Serum Tumor Necrosis Factor Alpha Concentration

  3 cycle of chemotherapy (63 days)

Study Arms (3)

Extra Virgin Olive Oil

EXPERIMENTAL

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

Dietary Supplement: Extra Virgin Olive Oil

Olive Oil

ACTIVE COMPARATOR

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

Dietary Supplement: Olive Oil

Placebo

PLACEBO COMPARATOR

The patients was given an empty capsule twice a day.

Dietary Supplement: Placebo

Interventions

Extra Virgin Olive Oil DIETARY_SUPPLEMENT

The patients was given extra virgin olive oil, an unrefined (not processed with chemicals or heat) for of olive oil

Also known as: EVOO

Extra Virgin Olive Oil

Olive Oil DIETARY_SUPPLEMENT

The patients was given olive oil.

Olive Oil

Placebo DIETARY_SUPPLEMENT

The patients was given empty capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitas Sriwijaya: lead

Study Sites (1)

Rumah Sakit Mohammad Hoesin

Palembang, South Sumatera, 30126, Indonesia

Location

Related Publications (5)

• Huang XZ, Chen Y, Chen WJ, Zhang X, Wu CC, Wang ZN, Wu J. Clinical evidence of prevention strategies for capecitabine-induced hand-foot syndrome. Int J Cancer. 2018 Jun 15;142(12):2567-2577. doi: 10.1002/ijc.31269. Epub 2018 Feb 2.

  PMID: 29355976 BACKGROUND

• Deng B, Sun W. Herbal medicine for hand-foot syndrome induced by fluoropyrimidines: A systematic review and meta-analysis. Phytother Res. 2018 Jul;32(7):1211-1228. doi: 10.1002/ptr.6068. Epub 2018 Apr 16.

  PMID: 29682836 BACKGROUND

• Elyasi S, Rasta S, Taghizadeh-Kermani A, Hosseini S. Topical henna and curcumin (Alpha(R)) ointment efficacy for prevention of capecitabine induced hand-foot syndrome: A randomized, triple-blinded, placebo-controlled clinical. Daru. 2022 Jun;30(1):117-125. doi: 10.1007/s40199-022-00438-8. Epub 2022 Mar 23.

  PMID: 35320555 BACKGROUND

• Zhang RX, Wu XJ, Wan DS, Lu ZH, Kong LH, Pan ZZ, Chen G. Celecoxib can prevent capecitabine-related hand-foot syndrome in stage II and III colorectal cancer patients: result of a single-center, prospective randomized phase III trial. Ann Oncol. 2012 May;23(5):1348-1353. doi: 10.1093/annonc/mdr400. Epub 2011 Sep 22.

  PMID: 21940785 RESULT

• Yap YS, Kwok LL, Syn N, Chay WY, Chia JWK, Tham CK, Wong NS, Lo SK, Dent RA, Tan S, Mok ZY, Koh KX, Toh HC, Koo WH, Loh M, Ng RCH, Choo SP, Soong RCT. Predictors of Hand-Foot Syndrome and Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Randomized Clinical Trial. JAMA Oncol. 2017 Nov 1;3(11):1538-1545. doi: 10.1001/jamaoncol.2017.1269.

  PMID: 28715540 RESULT

MeSH Terms

Conditions

Hand-Foot Syndrome

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hematology and Clinical Oncology Division, Department of Internal Medicine, Universitas Sriwijaya/Mohammad Hoesin General Hospital

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: January 3, 2024
• Study Start: January 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 20, 2024
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)