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NCT03580499 · ClinicalTrials.gov registry record · NA
Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
NCT03580499: Completed NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT03580499 is a NA study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 43 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03580499, a NA study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
Study Summary
This pilot phase II trial studies how well vitamin B6 works in reducing hot flashes in participants with prostate cancer undergoing antiandrogen therapy. A nutritional supplement such as vitamin B6 may help improve hot flashes caused by antiandrogen therapy in participants with prostate cancer.
Primary Outcome
For the primary analysis, the difference in the median response to the 10-point hot flash scale between 8-week post-treatment and pre-treatment responses will be computed with the corresponding 95% percent confidence interval. The primary null hypothesis will be tested using a two-sided Wilcoxon Signed-Rank Test with alpha=0.05.
Interventions
- OTHER Questionnaire Administration
- DIETARY_SUPPLEMENT Vitamin B6
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2018-09-13 |
| Est. Completion | 2024-07-01 |
| Phase | NA |
What the finished NCT03580499 record still lists
NCT03580499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Questionnaire Administration is the first listed.
NCT03580499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03580499 about?
NCT03580499 is a clinical study titled "Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy". This pilot phase II trial studies how well vitamin B6 works in reducing hot flashes in participants with prostate cancer undergoing antiandrogen therapy. A nutritional supplement such as vitamin B6 may help improve hot flashes caused by antiandrogen therapy in participants with prostate cancer.
What is the current status of trial NCT03580499?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2018-09-13. Estimated completion is 2024-07-01.
What interventions are being tested in trial NCT03580499?
The interventions under investigation include: Questionnaire Administration (OTHER), Vitamin B6 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03580499?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03580499's enrollment target sits among peer trials
43 1435th of 2000 higher than 565 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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