Clinical trial NCT06188000: Efficacy of Extra Virgin Olive Oil (EVOO) Supplementation on Hand-Foot Syndrome Incidence in Patients With Capecitabine
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hand and Foot Skin Reaction
Hand and Foot Syndrome
Capecitabine
Lead sponsor: Universitas Sriwijaya
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hand Foot Syndrome
timeFrame: 3 cycle of chemotherapy (63 days)
measure: Serum COX-2 Concentration
timeFrame: 3 cycle of chemotherapy (63 days)
measure: Serum malondialdehyde concentration
timeFrame: 3 cycle of chemotherapy (63 days)
measure: Serum Tumor Necrosis Factor Alpha Concentration
timeFrame: 3 cycle of chemotherapy (63 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Palembang
country: Indonesia
facility: Rumah Sakit Mohammad Hoesin
state: South Sumatera
Study officials:
References:
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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.
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;23(5):1348-1353. doi: 10.1093/annonc/mdr400. Epub 2011 Sep 22.
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 Syndrome: A Randomized Clinical Trial. JAMA Oncol. 2017 Nov 1;3(11):1538-1545. doi: 10.1001/jamaoncol.2017.1269.