Hand Foot Skin SyndromePhase 2NCT01097850
Topical Henna Preparation for the Treatment of Hand Foot Skin Syndrome
A Phase 2 study testing henna paste in people with Hand Foot Skin Syndrome, run by Northwestern University.
Trial summary
The purpose of this study is to determine whether henna paste is effective in the treatment of hand-foot skin syndrome, induced by the drugs Capecitabine and pegylated liposomal doxorubicin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Foot Skin Syndrome
- What is being tested?
- henna paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Jan 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 receiving capecitabine and/or pegylated liposomal doxorubicin as monotherapy or in combination with other agents
- New diagnosis of active hand-foot skin reaction (on bilateral hands and/or bilateral feet) of 1-3 toxicity as defined by the NCI-CTCAE version 4.0 grading scale with onset of symptoms within the last thirty days
- Patients must be 18 years or older
- Patients must provide written informed consent to participate in the study
Who cannot join
- Patients with pre-existing dermatological condition affecting the hands or feet that may limit the interpretation of results
- Known allergy to natural henna
- Patients with a previous history of HFS
- History of G6PD deficiency as determined by screening bloodwork
About this study
Official title: Prospective Randomized Controlled Open-label Trial of a Topical Henna Preparation for the Treatment of Hand-Foot Skin Syndrome and Its Associated Symptoms
The purpose of this study is to determine whether henna paste is effective in the treatment of hand-foot skin syndrome, induced by the drugs Capecitabine and pegylated liposomal doxorubicin.
- Conditions
- Hand Foot Skin Syndrome
- Being tested
- henna paste
- Keywords
- hand foot skin syndrome, palmar plantar erythrodysesthesia, doxorubicin, capecitabine
- 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.
henna pasteDrug
Henna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet
| Study group | Role | What they receive |
|---|---|---|
| Right | Other | Application of henna paste to right hand/foot plus CeraVe moisturizer Receives: Drug: henna paste |
| Left | Other | Application of henna paste to the left hand/foot plus CeraVe moisturizer Receives: Drug: henna paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To compare the severity of HFS in subjects receiving topical natural henna paste treatment along with using CeraVe™ moisturizing cream concurrently on the treatment side and using only CeraVe™ moisturizing cream on the control side.
Measured: 3 weeks
Secondary outcomes (1)
To examine quality of life, comparing natural henna treatment versus CeraVe™ alone, using the Skindex-16 questionnaire
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: No subject accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand Foot Skin SyndromeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis West, Northwestern University
- Investigators
- Peter Lio, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097850
- Sponsor's protocol ID
- NU 09D1
- Status last verified
- Dec 2014
- First submitted
- 31 Mar 2010
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Open-label Trial of a Topical Henna Preparation for the Treatment of Hand-Foot Skin Syndrome and Its Associated Symptoms
- ClinicalTrials.gov ID
- NCT01097850
- Acronym / sponsor ID
- NU 09D1
- Conditions
- Hand Foot Skin Syndrome
- Keywords
- hand foot skin syndrome, palmar plantar erythrodysesthesia, doxorubicin, capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subject accrual.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Apr 2010 (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.
The purpose of this study is to determine whether henna paste is effective in the treatment of hand-foot skin syndrome, induced by the drugs Capecitabine and pegylated liposomal doxorubicin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right | Other | Drug: henna pasteApplication of henna paste to right hand/foot plus CeraVe moisturizer |
| Left | Other | Drug: henna pasteApplication of henna paste to the left hand/foot plus CeraVe moisturizer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients receiving capecitabine and/or pegylated liposomal doxorubicin as monotherapy or in combination with other agents
- New diagnosis of active hand-foot skin reaction (on bilateral hands and/or bilateral feet) of 1-3 toxicity as defined by the NCI-CTCAE version 4.0 grading scale with onset of symptoms within the last thirty days
- Patients must be 18 years or older
- Patients must provide written informed consent to participate in the study
Key exclusion criteria (4 listed)
- Patients with pre-existing dermatological condition affecting the hands or feet that may limit the interpretation of results
- Known allergy to natural henna
- Patients with a previous history of HFS
- History of G6PD deficiency as determined by screening bloodwork
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 |
|---|---|---|
| henna pasteHenna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet | Drug | Left, Right |
Primary outcome
• To compare the severity of HFS in subjects receiving topical natural henna paste treatment along with using CeraVe™ moisturizing cream concurrently on the treatment side and using only CeraVe™ moisturizing cream on the control side.
Time frame: 3 weeks
1 secondary outcome
To examine quality of life, comparing natural henna treatment versus CeraVe™ alone, using the Skindex-16 questionnaire
Time frame: 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
Related trials for Hand Foot Skin Syndrome
Not yet recruitingEarly Phase 1
Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome
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SHIELD: Sorafenib Hand-foot Syndrome Inhibition With Pre-Emptive Local Delivery of Topical Indomethacin
Hepato Cellular Carcinoma (HCC), Hand Foot Skin Syndrome
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TAR-0520 Gel in Hand and Foot Syndrome
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The Efficacy and Safety of Mecobalamin in the Prevention of Capecitabine Induced Hand Foot Syndrome
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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.
Peter Lio, MD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing henna paste in people with Hand Foot Skin Syndrome, run by Northwestern University.
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 4 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: withdrawn, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
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 was withdrawn before enrolling participants, so there are no results.
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?
• To compare the severity of HFS in subjects receiving topical natural henna paste treatment along with using CeraVe™ moisturizing cream concurrently on the treatment side and using only CeraVe™ moisturizing cream on the control side. (time frame: 3 weeks). 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 12 Dec 2014.