A Pilot Study- Prevention of Capecitabine Induced Hand and Foot Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rabin Medical Center
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- skin feet toxicity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of stage IV cancer - treated with Capecitabine
Exclusion Criteria
- •Any patient who can not sign an informed consent
- •Pregnant women
Outcomes
Primary Outcomes
skin feet toxicity
Time Frame: 1 year
within the first year from starting Capecitabine use
Secondary Outcomes
No secondary outcomes reported
Investigators
rinat yerushalmi
Medical Oncologist
Rabin Medical Center