The Effect of Topical Brimonidine Tartrate on Hand-foot Syndrome (HFS) in Cancer Patients

NCT03173365 | Terminated Phase 2

• 1 other identifier: BRIMOCAN
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hand-foot Syndrome

Keywords

Hand-foot Syndrome; Brimonidine; Mirvaso; palmar-plantar erythrodysesthesia syndrome; Brimonidine Tartrate

Outcome Measures

Primary Outcomes (1)

• 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

  weekly up to 6 weeks

Secondary Outcomes (6)

• NCI-CTCAE v4.0 grading of HFS severity

  weekly up to 6 weeks

• Severity of nail toxicity

  weekly up to 6 weeks

• modified ppPASI grading of HFS severity

  weekly up to 6 weeks

• computer-assisted quantification of HFS severity

  weekly up to 6 weeks

• HFS associated pain (by VAS scale)

  weekly up to 6 weeks

Study Arms (1)

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.

Drug: Brimonidine Tartrate

Interventions

Brimonidine Tartrate DRUG

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.

Also known as: Mirvaso

Brimonidine Tartrate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Universitätsklinikum Düsseldorf, Klinik für Dermatologie

Düsseldorf, 40225, Germany

Location

MeSH Terms

Conditions

Hand-Foot Syndrome

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Peter Arne Gerber, PD Dr. med.

  Heinrich-Heine University, Duesseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 1, 2017
• Study Start: July 10, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)