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

Capecitabine Clinical Trial

— EVOO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06188000
• Other study ID #: 069/kepkrsmh/2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: January 2024
• Source: Universitas Sriwijaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 20, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Capecitabine
• Hand and Foot Syndrome
• Hand-Foot Syndrome
• Syndrome

Intervention

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
• Olive Oil
The patients was given olive oil.
• Placebo
The patients was given empty capsule

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Mohammad Hoesin	Palembang	South Sumatera

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Sriwijaya

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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 Syndrom — View Citation

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;2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Serum COX-2 Concentration	Serum COX-2 Concentration	3 cycle of chemotherapy (63 days)
Primary	Serum malondialdehyde concentration	Serum malondialdehyde ceoncentration	3 cycle of chemotherapy (63 days)
Primary	Serum Tumor Necrosis Factor Alpha Concentration	Serum Tumor Necrosis Factor Alpha Concentration	3 cycle of chemotherapy (63 days)