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Prevention of Capecitabine Induced Hand and Foot Syndrome

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ClinicalTrials.gov Identifier: NCT01291628
Recruitment Status : Unknown
Verified January 2012 by rinat yerushalmi, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 8, 2011
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
rinat yerushalmi, Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Cancer Device: socks containing copper-oxide fibers Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study- Prevention of Capecitabine Induced Hand and Foot Syndrome
Study Start Date : January 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: socks containing copper-oxide fibers 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.
Other Name: Cupron company EPA :84542-2, 84542-3 from April 30 2009.




Primary Outcome Measures :
  1. skin feet toxicity [ Time Frame: 1 year ]
    within the first year from starting Capecitabine use



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of stage IV cancer - treated with Capecitabine

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291628


Contacts
Contact: Rinat Yerusahlmi, MD 972-3-8024 rinaty@clalit.org.il
Contact: Aaron Sulkes, MD 972-3-7940 asulkes@clalit.org.il

Locations
Israel
Rabin Medical Center, Oncology department Not yet recruiting
Petach-Tikva, Israel, 49000
Contact: Rinat Yerusahlmi, MD    972-3-8024    rinaty@clalit.org.il   
Principal Investigator: Rinat Yerusahlmi, MD         
Principal Investigator: Aaron Sulkes, MD         
Sub-Investigator: Shtemmer Salomon, MD         
Sub-Investigator: Baruch Brenner, MD         
Sub-Investigator: Ofer Purim, MD         
Sub-Investigator: Victoria Neiman, MD         
Sub-Investigator: Noa Choraro, MD         
Sub-Investigator: Eyal Fenig, MD         
Sub-Investigator: Yulia Kundel, MD         
Sub-Investigator: Shulamith Rizel, MD         
Sub-Investigator: Luisa Bonila, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: 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

Publications:

Responsible Party: rinat yerushalmi, Medical Oncologist, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01291628     History of Changes
Other Study ID Numbers: Socks
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012

Keywords provided by rinat yerushalmi, Rabin Medical Center:
Capecitabine
Hand and foot syndrome
Socks
Copper
Toxicity

Additional relevant MeSH terms:
Hand-Foot Syndrome
Drug Eruptions
Dermatitis
Skin Diseases
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Capecitabine
Copper
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs