Hand-foot SyndromePhase 2NCT01609166
Effectiveness Allopurinol Topical Agent Prevention Capecitabine-induced Hand-foot Syndrome
A Phase 2 study testing Allopurinol in people with Hand-foot Syndrome, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial is conducted on the basis of preliminary data that a 3% allopurinol-based topical agent may prevent HFS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand-foot Syndrome
- What is being tested?
- Allopurinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2011to Dec 2012
- Phase
- Phase 2
- 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
- Patients older than 18years-old,that initiate treatment with oral capecitabine, without signs of hand-feet syndrome toxicity.
- Free acceptance to participate part in this clinical trial, with signature of the form of informed assent approved for the study, writing of the volunteer.
Who cannot join
- Age lower than 18 years
- Precedents of allergy, idiosyncrasy or hypersensitivity to the medicament.
- Denial of the patient to sign the informed assent.
- Any disorder or current / previous treatment that, in the opinion of the investigator, incapacitates the patient to take part in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo-controlled Trial to Determine the Effectiveness of a 3% Allopurinol-base Topical Agent for Prevention of Capecitabine-induced Hand-foot Syndrome
Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial is conducted on the basis of preliminary data that a 3% allopurinol-based topical agent may prevent HFS.
A randomized, double-blind phase III trial will evaluate 40 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients will be randomly assigned to a 3% allopurinol versus a placebo cream, which will be applied to the hands and feet twice per day for 6 months after the start of capecitabine. Patients will be examined every month and the investigators will take some photographs of hands and feet. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE]v3.0) will be also collected at baseline and at the end of each cycle. The primary end point is the incidence of moderate/severe HFS symptoms at the end of capecitabine treatment , based on the patient-reported dermatological exploration.
- Conditions
- Hand-foot Syndrome
- Being tested
- Allopurinol, Placebo
- Keywords
- Hand-foot Syndrome, capecitabine, allopurinol
- Medical subject headings
- Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Allopurinol 3% cream application in one side of the body, twice a day for 6 months
PlaceboDrug
Placebo cream application in the other side of the body, twice a day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol 3% cream | Experimental | Allopurinol 3% cream in one side of the body Receives: Drug: Allopurinol |
| Placebo cream | Placebo comparator | Placebo cream in the other side of the body Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the signs of hand-foot syndrome
Erythema, descamation, vesiculation
Measured: At 1-2-3-4-5-6 months
Secondary outcomes (1)
Changes in the symptoms of hand-foot syndrome
Burning, prurigo
Measured: At 1-2-3-4-5-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startJul 2011
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand-foot SyndromeStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609166
- Sponsor's protocol ID
- IIB-ALO-2010-02
- Other IDs
- 2010-022095-31
- Status last verified
- May 2014
- First submitted
- 24 May 2012
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled Trial to Determine the Effectiveness of a 3% Allopurinol-base Topical Agent for Prevention of Capecitabine-induced Hand-foot Syndrome
- ClinicalTrials.gov ID
- NCT01609166
- Acronym / sponsor ID
- IIB-ALO-2010-02
- Conditions
- Hand-foot Syndrome
- Keywords
- Hand-foot Syndrome, capecitabine, allopurinol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 May 2012 (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.
Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial is conducted on the basis of preliminary data that a 3% allopurinol-based topical agent may prevent HFS.
A randomized, double-blind phase III trial will evaluate 40 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients will be randomly assigned to a 3% allopurinol versus a placebo cream, which will be applied to the hands and feet twice per day for 6 months after the start of capecitabine. Patients will be examined every month and the investigators will take some photographs of hands and feet. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE]v3.0) will be also collected at baseline and at the end of each cycle. The primary end point is the incidence of moderate/severe HFS symptoms at the end of capecitabine treatment , based on the patient-reported dermatological exploration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol 3% cream | Experimental | Drug: AllopurinolAllopurinol 3% cream in one side of the body |
| Placebo cream | Placebo comparator | Drug: PlaceboPlacebo cream in the other side of the body |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients older than 18years-old,that initiate treatment with oral capecitabine, without signs of hand-feet syndrome toxicity.
- Free acceptance to participate part in this clinical trial, with signature of the form of informed assent approved for the study, writing of the volunteer.
Key exclusion criteria (4 listed)
- Age lower than 18 years
- Precedents of allergy, idiosyncrasy or hypersensitivity to the medicament.
- Denial of the patient to sign the informed assent.
- Any disorder or current / previous treatment that, in the opinion of the investigator, incapacitates the patient to take part in the study.
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 |
|---|---|---|
| AllopurinolAllopurinol 3% cream application in one side of the body, twice a day for 6 months | Drug | Allopurinol 3% cream |
| PlaceboPlacebo cream application in the other side of the body, twice a day for 6 months | Drug | Placebo cream |
Primary outcome
Changes in the signs of hand-foot syndrome
Time frame: At 1-2-3-4-5-6 months
Erythema, descamation, vesiculation
1 secondary outcome
Changes in the symptoms of hand-foot syndrome
Time frame: At 1-2-3-4-5-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
Related trials for Hand-foot Syndrome
Not yet recruitingEarly Phase 1
Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome
Palmar and Plantar Erythema, Numbness of the Four Limbs
RecruitingPhase 2
SHIELD: Sorafenib Hand-foot Syndrome Inhibition With Pre-Emptive Local Delivery of Topical Indomethacin
Hepato Cellular Carcinoma (HCC), Hand Foot Skin Syndrome
Not yet recruiting
Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5% Plasters in Oncology Patients Affected by Hand-foot Syndrome (HFS)
HFS
Not yet recruitingPhase 2
TAR-0520 Gel in Hand and Foot Syndrome
Hand and Foot Syndrome
Active, not recruitingPhase 3
The Efficacy and Safety of Mecobalamin in the Prevention of Capecitabine Induced Hand Foot Syndrome
Hand-foot Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allopurinol in people with Hand-foot Syndrome, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 23 May 2014. 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the signs of hand-foot syndrome (time frame: At 1-2-3-4-5-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2014.