Status:
COMPLETED
Topical Sildenafil as Pre-Treatment for Hand-Foot Skin Reaction
Lead Sponsor:
Northwestern University
Conditions:
Hand Foot Skin Reaction
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Skin toxicities are a major complication to cancer therapies. They can be painful and limit the amount of drug that can be received by cancer patients, preventing the patients from receiving optimal d...
Detailed Description
The purpose of this study is to evaluate the effect of topical sildenafil as a pre-treatment regimen for HFSR in patients naïve to anti-cancer therapy who will be initiated on treatment with sorafenib...
Eligibility Criteria
Inclusion
- Patients with a clinical diagnosis of cancer that are within ± 3 days of initiating treatment with sorafenib or sunitinib. Patients treated with a combination regimen that includes sorafenib or sunitinib are eligible.
- Patients must be age ≥ 18 years.
- Patients must exhibit an ECOG performance status of 0 to 2.
- Females of child-bearing potential (FOCBP) and males must agree to use adequate contraception (e.g., hormonal contraceptives such as birth control pills, patch, intrauterine device; barrier contraception such as male/female condoms, diaphragm; male partner with vasectomy; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy or has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months).
- FOCBP must have a negative urine or serum pregnancy test within 7 days prior to registration on study.
- Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration in the study.
Exclusion
- Patients with a prior diagnosis of hand-foot skin reaction are not eligible.
- Patients who have had other chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are not eligible.
- Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to sildenafil or phosphodiesterase-5 (PDE5) inhibitors such as vardenafil (Levitra) and tadalafil (Cialis) are not eligible.
- Patients may not be receiving any other investigational agents. Note: it is acceptable to be on combination therapy including either sorafenib and/or sunitinib.
- Patients must not be using topical steroids (e.g., hydrocortisone). Topical over-the-counter antibiotics (e.g., Neosporin) and skin protectants (e.g., Vaseline, Aquaphor) for local skin fissures on hands and feet are allowed. Patients are allowed to use topical medications on other body parts, besides the hands and feet, but must use qtips or gloves for application.
- Patients taking nitrates (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate) and/or alpha blockers (e.g., tamsulosin, prazosin, afluzosin, silodosin) are not eligible.
- Patients taking Viagra must have a 1 day washout period prior to treatment. Note: patients must agree to discontinue Viagra while on study treatment.
- Female patients who are pregnant or nursing are not eligible.
- Patients must not have any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study.
- Patients who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible.
Key Trial Info
Start Date :
April 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03229512
Start Date
April 11 2017
End Date
June 4 2020
Last Update
November 1 2021
Active Locations (2)
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1
Department of Dermatology, Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
2
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611