Hand and Foot Skin Reaction, Hand and Foot Syndrome, Capecitabine
Conditions
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.
Interventions
DIETARY_SUPPLEMENTExtra Virgin Olive Oil
The patients was given extra virgin olive oil, an unrefined (not processed with chemicals or heat) for of olive oil
DIETARY_SUPPLEMENTOlive Oil
The patients was given olive oil.
DIETARY_SUPPLEMENTPlacebo
The patients was given empty capsule
Sponsors
Universitas Sriwijaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hand Foot Syndrome | 3 cycle of chemotherapy (63 days) | 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. |
| Serum COX-2 Concentration | 3 cycle of chemotherapy (63 days) | Serum COX-2 Concentration |
| Serum malondialdehyde concentration | 3 cycle of chemotherapy (63 days) | Serum malondialdehyde ceoncentration |
| Serum Tumor Necrosis Factor Alpha Concentration | 3 cycle of chemotherapy (63 days) | Serum Tumor Necrosis Factor Alpha Concentration |
Countries
Indonesia
Outcome results
None listed