CancerNCT01291628
Prevention of Capecitabine Induced Hand and Foot Syndrome
A study testing socks containing copper-oxide fibers in people with Cancer, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- socks containing copper-oxide fibers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of stage IV cancer - treated with Capecitabine
Who cannot join
- Any patient who can not sign an informed consent
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rabin Medical Center, Oncology department
Petah Tikva, 49000
Rinat Yerusahlmi, MD, 972-3-8024, rinaty@clalit.org.il
Rinat Yerusahlmi, MD
About this study
Official title: A Pilot Study- Prevention of Capecitabine Induced Hand and Foot Syndrome
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- socks containing copper-oxide fibers
- Keywords
- Capecitabine, Hand and foot syndrome, Socks, Copper, Toxicity
- Medical subject headings
- Neoplasms, Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socks containing copper-oxide fibersDevice
Also called Cupron company EPA :84542-2, 84542-3 from April 30 2009.
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.
| Study group | Role | What they receive |
|---|---|---|
| socks containing copper-oxide fibers | Experimental | Not described Receives: Device: socks containing copper-oxide fibers |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin feet toxicity
within the first year from starting Capecitabine use
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rinat yerushalmi, Rabin Medical Center
- Investigators
- Rinat Yerushalmi, MD, Principal investigator, Rabin Medical Center, Affiliated to Tel-Aviv University, Tel-Aviv, IsraelAaron Sulkes, MD, Principal investigator, Rabin Medical Center affilated to Tel-Aviv University, Tel-Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291628
- Sponsor's protocol ID
- Socks
- Status last verified
- Jan 2012
- First submitted
- 7 Feb 2011
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11304782Van 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.
PubMed 11689577Abushullaih 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.
PubMed 11853000Cassidy 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.
PubMed 12056707Borkow 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.
PubMed 15345689Ueda 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.
PubMed 6444372Karlstrom 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.
PubMed 2062837Kim 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.
PubMed 11051099Cervantes 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.
PubMed 8049096Sen 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.
PubMed 11959648
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study- Prevention of Capecitabine Induced Hand and Foot Syndrome
- ClinicalTrials.gov ID
- NCT01291628
- Acronym / sponsor ID
- Socks
- Conditions
- Cancer
- Keywords
- Capecitabine, Hand and foot syndrome, Socks, Copper, Toxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| socks containing copper-oxide fibers | Experimental | Device: socks containing copper-oxide fibers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of stage IV cancer - treated with Capecitabine
Key exclusion criteria (2 listed)
- Any patient who can not sign an informed consent
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| socks containing copper-oxide fibersAlso: Cupron company EPA :84542-2, 84542-3 from April 30 2009.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. | Device | socks containing copper-oxide fibers |
Primary outcome
skin feet toxicity
Time frame: 1 year
within the first year from starting Capecitabine use
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
- Background: PubMed 11304782Hoff 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.
- Background: PubMed 11689577Van 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.
- Background: PubMed 11853000Abushullaih 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.
- Background: PubMed 12056707Cassidy 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.
- Background: PubMed 15345689Borkow 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.
- Background: PubMed 6444372Ueda 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.
- Background: PubMed 2062837Karlstrom 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.
- Background: PubMed 11051099Kim 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.
- Background: PubMed 8049096Cervantes 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.
- Background: PubMed 11959648Sen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rinat Yerushalmi, MD principal investigator
Rabin Medical Center, Affiliated to Tel-Aviv University, Tel-Aviv, Israel
Aaron Sulkes, MD principal investigator
Rabin Medical Center affilated to Tel-Aviv University, Tel-Aviv, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing socks containing copper-oxide fibers in people with Cancer, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rinat Yerusahlmi, MD (972-3-8024, rinaty@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin feet toxicity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291628, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2012.