Topical Sildenafil as Pre-Treatment for Hand-Foot Skin Reaction (NCT03229512) | Clinical Trial Compass
CompletedEarly Phase 1
Topical Sildenafil as Pre-Treatment for Hand-Foot Skin Reaction
United States2 participantsStarted 2017-04-11
Plain-language 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 doses of drug. One such cutaneous toxicity, hand-foot skin reaction (HFSR), is caused by next generation targeted agents that are in routine use for the treatment of kidney and liver cancer. HFSR is characterized by swelling, redness, and pain of the palms and soles, in addition to the development of painful or thickened callus-like plaques with fissures in areas of friction and pressure. The investigators have identified a topical skin-directed therapy, 1% topical sildenafil cream, that the investigators believe will be useful in preventing and ameliorating this painful, skin side effect associated with the targeted agents sorafenib and sunitinib. This project proposal aims to conduct an open-label pilot study to assess whether pre-medication with this cream can be an effective way of preventing or decreasing the severity of hand-foot skin reaction, improving their quality of life on therapy and enabling the patients to receive optimal amounts of their anti-cancer drug.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.