Hand-foot SyndromePhase 2BRIMOCANNCT03173365
The Effect of Topical Brimonidine Tartrate on Hand-foot Syndrome (HFS) in Cancer Patients
A Phase 2 study testing Brimonidine Tartrate in people with Hand-foot Syndrome, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Comparative analysis of the severity of Hand-Foot-Syndrome (HFS) of palms treated with brimonidine tartrate gel or with standard care Urea 10% containing lotion in cancer patients receiving antineoplastic therapy to show a preventive effect of cutaneous brimonidine treatment on severity of HFS symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hand-foot Syndrome
- What is being tested?
- Brimonidine Tartrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jul 2017to 31 Dec 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients with solid tumors under antineoplastic therapy with capecitabine or pegylated liposomal doxorubicin.
- Patients with a life expectancy of at least 12 weeks.
- History of HFS (grades 2 to 3) in the course of the therapy
- Patients who are 18-65 years old.
- Regression of HFS to grade 1 or lower with a symmetrical grading on both hands (grade 0 or grade 1) prior to the next cycle of chemotherapy.
- not legally incapacitated
- Written informed consent from the trial subject has been obtained.
- Current treatment with capecitabine or pegylated liposomal doxorubicin
Who cannot join
- Persons with any kind of dependency on the investigator or employed by the sponsor or investigator.
- Persons held in an institution by legal or official order.
- Participation in other interventional trials
- Drug \& substance abuse
- Use of central nervous depressants (e.g. alcohol, barbiturates, opiates, sedatives or anaesthetics)
- Patients taking alpha adrenergic agonists as medication.
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- Pregnant women and nursing mothers
- Failure to use highly-effective contraceptive methods
- The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly effective:
- Oral hormonal contraception ('pill')
- Vaginal hormonal contraception (NuvaRing®)
- Contraceptive plaster
- Long-acting injectable contraceptives
- Implants that release progesterone (Implanon®)
- Tubal ligation (female sterilization)
- Intrauterine devices that release hormones (hormone spiral)
- Double barrier methods: This means that the following are not regarded as safe: condom plus spermicide, simple barrier methods (vaginal pessaries, condom, female condoms), copper spirals, the rhythm method, basal temperature method, and the withdrawal method (coitus interruptus).
- History of inflammatory dermatosis of hands or feet (e.g. hand eczema)
- Smoking
- Severe or unstable or uncontrolled cardiovascular disease
- Depression
- cerebral or coronary insufficiency
- Raynaud's phenomenon
- orthostatic hypotension
- thrombangiitis obliterans
- Scleroderma
- Sjögren's syndrome
- renal or hepatic impairment
- Known allergic sensitization against any of the substances applied in the study
- Patients receiving monoamine oxidase (MAO) inhibitor therapy (for example selegiline or moclobemide) and patients on tricyclic (such as imipramine) or tetracyclic (such as maprotiline, mianserin or mirtazapin) antidepressants which affect noradrenergic transmission.
- Patients receiving topical corticoids on hands or feet within 1 week prior to baseline measurement and during the entire study treatment period of up to six weeks.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Düsseldorf, Klinik für Dermatologie
Düsseldorf, 40225
About this study
Official title: Half-Side Controlled Analysis of the Effect of Topical Brimonidine Tartrate on the Frequency and Severity of Hand-Foot Syndrome (HFS) in Cancer Patients Receiving Antineoplastic Agents (BRIMOCAN)
Comparative analysis of the severity of Hand-Foot-Syndrome (HFS) of palms treated with brimonidine tartrate gel or with standard care Urea 10% containing lotion in cancer patients receiving antineoplastic therapy to show a preventive effect of cutaneous brimonidine treatment on severity of HFS symptoms.
Read the detailed description
Hand-foot syndrome (HFS) is an adverse event frequently associated with the use of classical chemotherapeutic agents such as capecitabine or pegylated liposomal doxorubicin, as well as targeted cancer drugs such as sorafenib or other tyrosine-kinase inhibitors. If the toxicity progresses edematous swelling, blistering and desquamation can lead to ulcerations of the palms and soles. Additionally, patients may be affected by nail-toxicities, such as discoloration, ridging, pitting up to complete onycholysis and pain. Today, cooling of hands and feet during infusion chemotherapy as well as preventive treatment with topical formulations containing urea 10% (e.g. Excipial U10 Lipolotion®) is considered as standard of care. Yet, these strategies are limited by intricateness, patient inconvenience and low efficacy. Hence, at this point the satisfactory treatment of HFS remains an unmet medical need, as until now, no effective therapy is available to prevent or reduce HFS symptoms during the cycle of chemotherapeutic treatment.
Recently, brimonidine 3 mg/g gel (Mirvaso®) has been approved as a topical treatment of facial erythema of rosacea in adult patients. Brimonidine is an effective agonist of α2-adrenoreceptors thereby, in analogy to skin cooling, leading to peripheral vasoconstriction.
Against this background, the following hypothesis was developed:
The topical application brimonidine 3 mg/g gel (Mirvaso®) may prevent or reduce the severity of HFS in cancer patients that receive respective antineoplastic agents.
- Conditions
- Hand-foot Syndrome
- Being tested
- Brimonidine Tartrate
- Keywords
- Hand-foot Syndrome, Brimonidine, Mirvaso, palmar-plantar erythrodysesthesia syndrome, Brimonidine Tartrate
- 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.
Brimonidine TartrateDrug
Also called Mirvaso
1 gram of Brimonidine 3 mg/g gel (Mirvaso®) in 24 hours on the randomized palm equal to a finger tip unit (FTU) of 0.5 gram , topical application under occlusion twice per day, every 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Brimonidine Tartrate | Experimental | The respective palm to be treated with Brimonidine will be randomly assessed and will be matched for handedness to include equal numbers of dominant and non-dominant treated palms. Receives: Drug: Brimonidine Tartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and time of occurence of Palms with HFS severity grade 2 or 3
Palms with HFS severity of grade 2 or 3 during 2 cycles of chemotherapy or over 6 week period by means of the National Cancer Institute Common Terminology criteria for Adverse Events (NCI-CTCAE) v4.0 grading
Measured: weekly up to 6 weeks
Secondary outcomes (6)
NCI-CTCAE v4.0 grading of HFS severity
Severity of HFS after 2 cycles of chemotherapy or 6 weeks by means of the NCI-CTCAE v4.0 grading
Measured: weekly up to 6 weeks
Severity of nail toxicity
Severity of nail toxicity after 2 cycles of chemotherapy or 6 weeks by means of the NCI-CTCAE v3.0 grading
Measured: weekly up to 6 weeks
modified ppPASI grading of HFS severity
Severity of HFS after 2 cycles of chemotherapy or 6 weeks by means of a modified Palmoplantar Psoriasis Area Severity Index (ppPASI)
Measured: weekly up to 6 weeks
computer-assisted quantification of HFS severity
Severity of HFS after 2 cycles of chemotherapy or 6 weeks by means of computer-assisted quantification
Measured: weekly up to 6 weeks
HFS associated pain (by VAS scale)
Level of HFS-associated pain after 2 cycles of chemotherapy or 6 weeks by means of visual analogue scale (VAS)
Measured: weekly up to 6 weeks
Highest grade of HFS severity (NCI-CTCAE v4.0 grading)
Highest grade of HFS severity reached until 2 cycle of chemotherapy or over 6 week period by means of the NCI-CTCAE v4.0 grading
Measured: weekly up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start10 Jul 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: It is no longer practicable to complete the trial
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 Heinrich-Heine University, DuesseldorfThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- The respective palm to be treated will be randomly assessed and will be matched for handedness to include equal numbers of dominant and non-dominant treated palms.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Arne Gerber, PD Dr. med., Principal investigator, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173365
- Sponsor's protocol ID
- BRIMOCAN
- Acronym
- BRIMOCAN
- Status last verified
- Jan 2019
- First submitted
- 30 May 2017
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Half-Side Controlled Analysis of the Effect of Topical Brimonidine Tartrate on the Frequency and Severity of Hand-Foot Syndrome (HFS) in Cancer Patients Receiving Antineoplastic Agents (BRIMOCAN)
- ClinicalTrials.gov ID
- NCT03173365
- Acronym / sponsor ID
- BRIMOCAN / BRIMOCAN
- Conditions
- Hand-foot Syndrome
- Keywords
- Hand-foot Syndrome, Brimonidine, Mirvaso, palmar-plantar erythrodysesthesia syndrome, Brimonidine Tartrate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It is no longer practicable to complete the trial
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Jun 2017 (actual)
- 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.
Comparative analysis of the severity of Hand-Foot-Syndrome (HFS) of palms treated with brimonidine tartrate gel or with standard care Urea 10% containing lotion in cancer patients receiving antineoplastic therapy to show a preventive effect of cutaneous brimonidine treatment on severity of HFS symptoms.
Detailed description
Hand-foot syndrome (HFS) is an adverse event frequently associated with the use of classical chemotherapeutic agents such as capecitabine or pegylated liposomal doxorubicin, as well as targeted cancer drugs such as sorafenib or other tyrosine-kinase inhibitors. If the toxicity progresses edematous swelling, blistering and desquamation can lead to ulcerations of the palms and soles. Additionally, patients may be affected by nail-toxicities, such as discoloration, ridging, pitting up to complete onycholysis and pain. Today, cooling of hands and feet during infusion chemotherapy as well as preventive treatment with topical formulations containing urea 10% (e.g. Excipial U10 Lipolotion®) is considered as standard of care. Yet, these strategies are limited by intricateness, patient inconvenience and low efficacy. Hence, at this point the satisfactory treatment of HFS remains an unmet medical need, as until now, no effective therapy is available to prevent or reduce HFS symptoms during the cycle of chemotherapeutic treatment.
Recently, brimonidine 3 mg/g gel (Mirvaso®) has been approved as a topical treatment of facial erythema of rosacea in adult patients. Brimonidine is an effective agonist of α2-adrenoreceptors thereby, in analogy to skin cooling, leading to peripheral vasoconstriction.
Against this background, the following hypothesis was developed:
The topical application brimonidine 3 mg/g gel (Mirvaso®) may prevent or reduce the severity of HFS in cancer patients that receive respective antineoplastic agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The respective palm to be treated will be randomly assessed and will be matched for handedness to include equal numbers of dominant and non-dominant treated palms.
| Arm | Type | Receives |
|---|---|---|
| Brimonidine Tartrate | Experimental | Drug: Brimonidine TartrateThe respective palm to be treated with Brimonidine will be randomly assessed and will be matched for handedness to include equal numbers of dominant and non-dominant treated palms. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cancer patients with solid tumors under antineoplastic therapy with capecitabine or pegylated liposomal doxorubicin.
- Patients with a life expectancy of at least 12 weeks.
- History of HFS (grades 2 to 3) in the course of the therapy
- Patients who are 18-65 years old.
- Regression of HFS to grade 1 or lower with a symmetrical grading on both hands (grade 0 or grade 1) prior to the next cycle of chemotherapy.
Key exclusion criteria (31 listed)
- Persons with any kind of dependency on the investigator or employed by the sponsor or investigator.
- Persons held in an institution by legal or official order.
- Participation in other interventional trials
- Drug \& substance abuse
- Use of central nervous depressants (e.g. alcohol, barbiturates, opiates, sedatives or anaesthetics)
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 |
|---|---|---|
| Brimonidine TartrateAlso: Mirvaso1 gram of Brimonidine 3 mg/g gel (Mirvaso®) in 24 hours on the randomized palm equal to a finger tip unit (FTU) of 0.5 gram , topical application under occlusion twice per day, every 12 hours. | Drug | Brimonidine Tartrate |
Primary outcome
Number and time of occurence of Palms with HFS severity grade 2 or 3
Time frame: weekly up to 6 weeks
Palms with HFS severity of grade 2 or 3 during 2 cycles of chemotherapy or over 6 week period by means of the National Cancer Institute Common Terminology criteria for Adverse Events (NCI-CTCAE) v4.0 grading
6 secondary outcomes
NCI-CTCAE v4.0 grading of HFS severity
Time frame: weekly up to 6 weeks
Severity of nail toxicity
Time frame: weekly up to 6 weeks
modified ppPASI grading of HFS severity
Time frame: weekly up to 6 weeks
computer-assisted quantification of HFS severity
Time frame: weekly up to 6 weeks
HFS associated pain (by VAS scale)
Time frame: weekly up to 6 weeks
Highest grade of HFS severity (NCI-CTCAE v4.0 grading)
Time frame: weekly up to 6 weeks
Results and safety
The study was stopped early (reason given: It is no longer practicable to complete the trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: No
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.
Peter Arne Gerber, PD Dr. med. principal investigator
Heinrich-Heine University, Duesseldorf
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 Brimonidine Tartrate in people with Hand-foot Syndrome, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 8 inclusion and 31 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: stopped early, as of the sponsor's last update on 9 Jan 2019. 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 Germany. 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.
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 stopped early (reason given: It is no longer practicable to complete the trial). Results are not available in the source record.
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?
Number and time of occurence of Palms with HFS severity grade 2 or 3 (time frame: weekly up to 6 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 9 Jan 2019.