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NCT03229512 · ClinicalTrials.gov registry record · Early Phase 1
Topical Sildenafil as Pre-Treatment for Hand-Foot Skin Reaction
A Early Phase 1 study, sponsored by Northwestern University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
NCT03229512: Completed Early Phase 1 study, sponsored by Northwestern University.
NCT03229512 is a Early Phase 1 study that has completed, run by Northwestern University. The registered enrollment target is 2 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03229512, a Early Phase 1 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
Study 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.
Primary Outcome
The primary outcome measure is the onset and calculated incidence of any grade of hand-foot skin reaction during the 12-week study period.
Interventions
- DRUG Sildenafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2017-04-11 |
| Est. Completion | 2020-06-04 |
| Phase | Early Phase 1 |
What the finished NCT03229512 record still lists
NCT03229512 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Sildenafil is the first listed.
NCT03229512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03229512 about?
NCT03229512 is a clinical study titled "Topical Sildenafil as Pre-Treatment for Hand-Foot Skin Reaction". 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 generat...
What is the current status of trial NCT03229512?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2017-04-11. Estimated completion is 2020-06-04.
What interventions are being tested in trial NCT03229512?
The interventions under investigation include: Sildenafil (DRUG).
Who is sponsoring clinical trial NCT03229512?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03229512's enrollment target sits among peer trials
2 1974th of 2000 higher than 16 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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