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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
60
The patients was given extra virgin olive oil, an unrefined (not processed with chemicals or heat) for of olive oil
The patients was given olive oil.
The patients was given empty capsule
Rumah Sakit Mohammad Hoesin
Palembang, South Sumatera, Indonesia
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.
Time frame: 3 cycle of chemotherapy (63 days)
Serum COX-2 Concentration
Serum COX-2 Concentration
Time frame: 3 cycle of chemotherapy (63 days)
Serum malondialdehyde concentration
Serum malondialdehyde ceoncentration
Time frame: 3 cycle of chemotherapy (63 days)
Serum Tumor Necrosis Factor Alpha Concentration
Serum Tumor Necrosis Factor Alpha Concentration
Time frame: 3 cycle of chemotherapy (63 days)
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