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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extra Virgin Olive Oil | Experimental | The patients was given a capsule contained extra virgin olive oil 15 milliliters twice a day. |
|
| Olive Oil | Active Comparator | The patients was given a capsule contained olive oil 15 milliliters twice a day. |
|
| Placebo | Placebo Comparator | The patients was given an empty capsule twice a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra Virgin Olive Oil | Dietary Supplement | The patients was given extra virgin olive oil, an unrefined (not processed with chemicals or heat) for of olive oil |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Serum COX-2 Concentration | Serum COX-2 Concentration | 3 cycle of chemotherapy (63 days) |
| Serum malondialdehyde concentration | Serum malondialdehyde ceoncentration | 3 cycle of chemotherapy (63 days) |
| Serum Tumor Necrosis Factor Alpha Concentration | Serum Tumor Necrosis Factor Alpha Concentration | 3 cycle of chemotherapy (63 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rumah Sakit Mohammad Hoesin | Palembang | South Sumatera | 30126 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29355976 | Background | 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. | |
| 29682836 | Background | 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. |
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The data will be shared after the completion of the study and has been subjected to the consent of the individual patients
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|
| Olive Oil | Dietary Supplement | The patients was given olive oil. |
|
| Placebo | Dietary Supplement | The patients was given empty capsule |
|
| 35320555 | Background | 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. |
| 21940785 | Result | 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. |
| 28715540 | Result | 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. |
| ID | Term |
|---|---|
| D060831 | Hand-Foot Syndrome |
| ID | Term |
|---|---|
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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