Clinical trial NCT01291628: Prevention of Capecitabine Induced Hand and Foot Syndrome
Official title: A Pilot Study- Prevention of Capecitabine Induced Hand and Foot Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: Capecitabine
Hand and foot syndrome
Socks
Copper
Toxicity
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-02-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: skin feet toxicity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Rabin Medical Center, Oncology department
Study officials:
affiliation: Rabin Medical Center, Affiliated to Tel-Aviv University, Tel-Aviv, Israel
name: Rinat Yerushalmi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rabin Medical Center affilated to Tel-Aviv University, Tel-Aviv, Israel
name: Aaron Sulkes, MD
role: PRINCIPAL_INVESTIGATOR
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