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Prevention of Capecitabine Induced Hand and Foot Syndrome

Primary Purpose

Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

socks containing copper-oxide fibers

About this trial

This is an interventional prevention trial for Cancer focused on measuring Capecitabine, Hand and foot syndrome, Socks, Copper, Toxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of stage IV cancer - treated with Capecitabine

Exclusion Criteria:

Any patient who can not sign an informed consent
Pregnant women

Sites / Locations

Rabin Medical Center, Oncology department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

socks containing copper-oxide fibers

Arm Description

Outcomes

Primary Outcome Measures

skin feet toxicity

within the first year from starting Capecitabine use

Secondary Outcome Measures

Full Information

NCT ID

NCT01291628

First Posted

February 7, 2011

Last Updated

January 18, 2012

Sponsor

Rabin Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01291628

Brief Title

Prevention of Capecitabine Induced Hand and Foot Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

January 2014 (Anticipated)

Study Completion Date

January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rabin Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer

Keywords

Capecitabine, Hand and foot syndrome, Socks, Copper, Toxicity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

socks containing copper-oxide fibers

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

socks containing copper-oxide fibers

Other Intervention Name(s)

Cupron company EPA :84542-2, 84542-3 from April 30 2009.

Intervention Description

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.

Primary Outcome Measure Information:

Title

skin feet toxicity

Description

within the first year from starting Capecitabine use

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rinat Yerusahlmi, MD

Phone

972-3-8024

rinaty@clalit.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Aaron Sulkes, MD

Phone

972-3-7940

asulkes@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rinat Yerushalmi, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Aaron Sulkes, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rabin Medical Center, Oncology department

City

Petach-Tikva

ZIP/Postal Code

49000

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rinat Yerusahlmi, MD

Phone

972-3-8024

rinaty@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Rinat Yerusahlmi, MD

First Name & Middle Initial & Last Name & Degree

Aaron Sulkes, MD

First Name & Middle Initial & Last Name & Degree

Shtemmer Salomon, MD

First Name & Middle Initial & Last Name & Degree

Baruch Brenner, MD

First Name & Middle Initial & Last Name & Degree

Ofer Purim, MD

First Name & Middle Initial & Last Name & Degree

Victoria Neiman, MD

First Name & Middle Initial & Last Name & Degree

Noa Choraro, MD

First Name & Middle Initial & Last Name & Degree

Eyal Fenig, MD

First Name & Middle Initial & Last Name & Degree

Yulia Kundel, MD

First Name & Middle Initial & Last Name & Degree

Shulamith Rizel, MD

First Name & Middle Initial & Last Name & Degree

Luisa Bonila, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

11304782

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. doi: 10.1200/JCO.2001.19.8.2282.

Results Reference

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PubMed Identifier

11689577

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. doi: 10.1200/JCO.2001.19.21.4097.

Results Reference

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PubMed Identifier

11853000

Citation

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Results Reference

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PubMed Identifier

12056707

Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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Prevention of Capecitabine Induced Hand and Foot Syndrome

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