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NCT03796195 · ClinicalTrials.gov registry record · Phase 4
(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes
A Phase 4 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT03796195 is a Phase 4 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 1 participants.
The verdict
NCT03796195, a Phase 4 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
Androgen Deprivation Therapy (ADT) is a critical component of advanced prostate cancer treatment but causes numerous adverse effects including decreased bone mass, decreased muscle mass, gynecomastia, erectile dysfunction, loss of sexual desire, depression, disordered sleep, urinary symptoms, and hot flashes (HF). HF are unpleasant paroxysmal episodes of flushing, sweating with vasodilation of the face, neck, and chest. These episodes can last for seconds to minutes and are often associated with night sweats, anxiety, and insomnia and have negative effects on quality of life. Stellate ganglion blockade (SGB) with local anesthetic may be an effective treatment of HF in men on ADT, but has not been studied in any published clinical trials. The stellate ganglion is a neural structure in the anterior cervical spine region and is part of the sympathetic nervous system. It has been injected safely in the practice of pain management for more than 50 years in cases of post herpetic neuralgia (shingles), complex regional pain syndrome (CRPS) and other painful neuropathies as well as some types of cardiac dysrhythmias. Given the frequency and severity and interference of HF in men on ADT for prostate cancer, in addition to the negative effects HF impose on this patient population and a paucity of effective treatments, finding alternative treatments for HF in this population is needed.
Interventions
- DRUG .5% Bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-11-13 |
| Est. Completion | 2021-07-16 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03796195
The ClinicalTrials.gov registry entry for NCT03796195 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which .5% Bupivacaine is the first listed.
NCT03796195 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03796195 about?
NCT03796195 is a clinical study titled "(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes". Androgen Deprivation Therapy (ADT) is a critical component of advanced prostate cancer treatment but causes numerous adverse effects including decreased bone mass, decreased muscle mass, gynecomastia, erectile dysfunction, loss of sexual desire, depression, disordered sleep, urinary symptoms, and ho...
What is the current status of trial NCT03796195?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2019-11-13. Estimated completion is 2021-07-16.
What interventions are being tested in trial NCT03796195?
The interventions under investigation include: .5% Bupivacaine (DRUG).
Who is sponsoring clinical trial NCT03796195?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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