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NCT01219023 · ClinicalTrials.gov registry record · Phase 1
Treatment of Palmar Plantar Erythrodysesthesia (PPE) With Topical Sildenafil
A Phase 1 study of Palmar-plantar Erythrodysesthesia and Hand Foot Syndrome, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01219023 is a Phase 1 study of Palmar-plantar Erythrodysesthesia and Hand Foot Syndrome that has completed, run by Duke University. The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01219023, a Phase 1 study of Palmar-plantar Erythrodysesthesia and Hand Foot Syndrome, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysethesia (PPE), occurs in a 25%-50% of patients treated with several commonly used anti-cancer drugs including capecitabine and sunitinib. These drugs are known to improve survival in many cancers, including cancers of the colon, stomach, liver, breast, kidney, and GI stromal tumors (GIST). Worldwide, over 400,000 patients per year are treated with one of these agents. HFS involves skin changes, such as swelling, peeling, and blistering of the palms and soles, which is often painful and debilitating. As a result, HFS-related symptoms can frequently lead to dose reduction and/or discontinuation of otherwise effective anti-cancer treatment. There is no treatment for HFS other than dose reduction or stopping treatment. This proposal could quickly lead to treatments to prevent and/or treat HFS and help patients avoid debilitating side effects while continuing otherwise effective treatments for their cancer.
Conditions Studied
Interventions
- DRUG sildenafil citrate
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01219023
The ClinicalTrials.gov registry entry for NCT01219023 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Palmar-plantar Erythrodysesthesia appearing as the primary indexed condition, and to 1 intervention - of which sildenafil citrate is the first listed.
NCT01219023 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01219023 about?
NCT01219023 is a clinical study titled "Treatment of Palmar Plantar Erythrodysesthesia (PPE) With Topical Sildenafil". Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysethesia (PPE), occurs in a 25%-50% of patients treated with several commonly used anti-cancer drugs including capecitabine and sunitinib. These drugs are known to improve survival in many cancers, including cancers of the colon, stomac...
What is the current status of trial NCT01219023?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2010-06. Estimated completion is 2012-04.
What conditions does trial NCT01219023 study?
This clinical trial studies the following conditions: Palmar-plantar Erythrodysesthesia, Hand Foot Syndrome.
What interventions are being tested in trial NCT01219023?
The interventions under investigation include: sildenafil citrate (DRUG).
Who is sponsoring clinical trial NCT01219023?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01219023 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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