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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06188000
Other study ID # 069/kepkrsmh/2022
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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