Prevention of Capecitabine Induced Hand and Foot Syndrome

Cancer Clinical Trial

Official title:

A Pilot Study- Prevention of Capecitabine Induced Hand and Foot Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01291628
• Other study ID #: Socks
• Status: Not yet recruiting
• Phase: N/A
• First received: February 7, 2011
• Last updated: January 18, 2012
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2012
• Source: Rabin Medical Center
• Contact: Rinat Yerusahlmi, MD
• Phone: 972-3-8024
• Email: rinaty[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Capecitabine is a common anti cancer drug. One of the most common side effects is a syndrome called hand and foot syndrome which comprises of hands and feet redness, swelling, dryness and painful sores. Quite often the drug dose is reduced to suboptimal level due to this side effect. There is no way to prevent or an effective way to treat this side effect. The investigators aim is to investigate whether wearing socks which contain copper fibers may prevent or alleviate the patient symptoms.

Description:

Capecitabine is a common anti cancer drug. One of the most common side effects is a syndrome called hand and foot syndrome which comprises of hands and feet redness, swelling, dryness and painful sores. Quite often the drug dose is reduced to suboptimal level due to this side effect. There is no way to prevent or an effective way to treat this side effect. Our aim is to investigate whether wearing socks which contain copper fibers may prevent or alleviate the patient symptoms.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of stage IV cancer - treated with Capecitabine

Exclusion Criteria:

• Any patient who can not sign an informed consent

• Pregnant women

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer
• Hand-Foot Syndrome

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Oncology department	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (10)

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. — View Citation

Borkow G, Gabbay J. Putting copper into action: copper-impregnated products with potent biocidal activities. FASEB J. 2004 Nov;18(14):1728-30. Epub 2004 Sep 2. — View Citation

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, Pérez-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. — View Citation

Cervantes C, Gutierrez-Corona F. Copper resistance mechanisms in bacteria and fungi. FEMS Microbiol Rev. 1994 Jun;14(2):121-37. Review. — View Citation

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. — View Citation

Karlström 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin feet toxicity	within the first year from starting Capecitabine use	1 year	No