NCT01291628

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

February 7, 2011

Last Update Submit

January 18, 2012

Conditions

Cancer

Keywords

CapecitabineHand and foot syndromeSocksCopperToxicity

Outcome Measures

Primary Outcomes (1)

  • skin feet toxicity

    within the first year from starting Capecitabine use

    1 year

Study Arms (1)

socks containing copper-oxide fibers

EXPERIMENTAL
Device: socks containing copper-oxide fibers

Interventions

socks containing copper-oxide fibersDEVICE

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.

Also known as: Cupron company EPA :84542-2, 84542-3 from April 30 2009.
socks containing copper-oxide fibers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of stage IV cancer - treated with Capecitabine

You may not qualify if:

  • Any patient who can not sign an informed consent
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center, Oncology department

Petah Tikva, 49000, Israel

Location

Related Publications (10)

  • 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.

    PMID: 11304782BACKGROUND

  • 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.

    PMID: 11689577BACKGROUND

  • 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.

    PMID: 11853000BACKGROUND

  • 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.

    PMID: 12056707BACKGROUND

  • 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.

    PMID: 15345689BACKGROUND

  • 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.

    PMID: 6444372BACKGROUND

  • 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.

    PMID: 2062837BACKGROUND

  • 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.

    PMID: 11051099BACKGROUND

  • 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.

    PMID: 8049096BACKGROUND

  • 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.

    PMID: 11959648BACKGROUND

MeSH Terms

Conditions

NeoplasmsHand-Foot Syndrome

Condition Hierarchy (Ancestors)

Drug EruptionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Officials

  • Rinat Yerushalmi, MD

    Rabin Medical Center, Affiliated to Tel-Aviv University, Tel-Aviv, Israel

    PRINCIPAL INVESTIGATOR

  • Aaron Sulkes, MD

    Rabin Medical Center affilated to Tel-Aviv University, Tel-Aviv, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rinat Yerusahlmi, MD

CONTACT

972-3-8024rinaty@clalit.org.il

Aaron Sulkes, MD

CONTACT

972-3-7940asulkes@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Oncologist

Study Record Dates

First Submitted

February 7, 2011

First Posted

February 8, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations

IL(1)