Prevention of Capecitabine Induced Hand and Foot Syndrome
NCT ID: NCT01291628
Last Updated: 2012-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2012-01-31
2014-01-31
Brief Summary
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Detailed Description
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The patients will use socks containing copper-oxide impregnated fibers which are sold in the Pharma stores without physician's prescription.(EPA numbers 8454-2, 8454-3 from April 30 2009).
Drug Toxicity and skin reaction will be documented.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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socks containing copper-oxide fibers
socks containing copper-oxide fibers
The patients will use a sock which contains copper fibers. The socks are sold in the free market (different Pharma stores) for various purposes such as prevention of diabetic foot. It is a product of Cupron company EPA :84542-2, 84542-3 from April 30 2009.
Interventions
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socks containing copper-oxide fibers
The patients will use a sock which contains copper fibers. The socks are sold in the free market (different Pharma stores) for various purposes such as prevention of diabetic foot. It is a product of Cupron company EPA :84542-2, 84542-3 from April 30 2009.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant women
18 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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rinat yerushalmi
Medical Oncologist
Principal Investigators
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Rinat Yerushalmi, MD
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center, Affiliated to Tel-Aviv University, Tel-Aviv, Israel
Aaron Sulkes, MD
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center affilated to Tel-Aviv University, Tel-Aviv, Israel
Locations
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Rabin Medical Center, Oncology department
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Hoff PM, Ansari R, Batist G, Cox J, Kocha W, Kuperminc M, Maroun J, Walde D, Weaver C, Harrison E, Burger HU, Osterwalder B, Wong AO, Wong R. Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: results of a randomized phase III study. J Clin Oncol. 2001 Apr 15;19(8):2282-92. doi: 10.1200/JCO.2001.19.8.2282.
Van Cutsem E, Twelves C, Cassidy J, Allman D, Bajetta E, Boyer M, Bugat R, Findlay M, Frings S, Jahn M, McKendrick J, Osterwalder B, Perez-Manga G, Rosso R, Rougier P, Schmiegel WH, Seitz JF, Thompson P, Vieitez JM, Weitzel C, Harper P; Xeloda Colorectal Cancer Study Group. Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. J Clin Oncol. 2001 Nov 1;19(21):4097-106. doi: 10.1200/JCO.2001.19.21.4097.
Abushullaih S, Saad ED, Munsell M, Hoff PM. Incidence and severity of hand-foot syndrome in colorectal cancer patients treated with capecitabine: a single-institution experience. Cancer Invest. 2002;20(1):3-10. doi: 10.1081/cnv-120000360.
Cassidy J, Twelves C, Van Cutsem E, Hoff P, Bajetta E, Boyer M, Bugat R, Burger U, Garin A, Graeven U, McKendric J, Maroun J, Marshall J, Osterwalder B, Perez-Manga G, Rosso R, Rougier P, Schilsky RL; Capecitabine Colorectal Cancer Study Group. First-line oral capecitabine therapy in metastatic colorectal cancer: a favorable safety profile compared with intravenous 5-fluorouracil/leucovorin. Ann Oncol. 2002 Apr;13(4):566-75. doi: 10.1093/annonc/mdf089.
Borkow G, Gabbay J. Putting copper into action: copper-impregnated products with potent biocidal activities. FASEB J. 2004 Nov;18(14):1728-30. doi: 10.1096/fj.04-2029fje. Epub 2004 Sep 2.
Ueda K, Morita J, Yamashita K, Komano T. Inactivation of bacteriophage phi X174 by mitomycin C in the presence of sodium hydrosulfite and cupric ions. Chem Biol Interact. 1980 Feb;29(2):145-58. doi: 10.1016/0009-2797(80)90029-0.
Karlstrom AR, Levine RL. Copper inhibits the protease from human immunodeficiency virus 1 by both cysteine-dependent and cysteine-independent mechanisms. Proc Natl Acad Sci U S A. 1991 Jul 1;88(13):5552-6. doi: 10.1073/pnas.88.13.5552.
Kim JH, Cho H, Ryu SE, Choi MU. Effects of metal ions on the activity of protein tyrosine phosphatase VHR: highly potent and reversible oxidative inactivation by Cu2+ ion. Arch Biochem Biophys. 2000 Oct 1;382(1):72-80. doi: 10.1006/abbi.2000.1996.
Cervantes C, Gutierrez-Corona F. Copper resistance mechanisms in bacteria and fungi. FEMS Microbiol Rev. 1994 Jun;14(2):121-37. doi: 10.1111/j.1574-6976.1994.tb00083.x.
Sen CK, Khanna S, Venojarvi M, Trikha P, Ellison EC, Hunt TK, Roy S. Copper-induced vascular endothelial growth factor expression and wound healing. Am J Physiol Heart Circ Physiol. 2002 May;282(5):H1821-7. doi: 10.1152/ajpheart.01015.2001.
Other Identifiers
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Socks
Identifier Type: -
Identifier Source: org_study_id
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