Clinical trial · Interventional
Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
A Pilot Study of the Effects of Vitamin B6 on Hot Flash Symptoms in Prostate Cancer Patients
NCT03580499CI-TRIAL-00096590completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hot Flashes | — | UNRESOLVED | — |
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire Administration | Other | — | UNRESOLVED |
| Vitamin B6 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care (vitamin B6)
- description
- Participants receive vitamin B6 PO daily for 12 weeks.
- interventionNames
- Dietary Supplement: Vitamin B6
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)
- timeFrame
- Baseline to 8 weeks
- description
- 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.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Subjects are currently receiving ADT for prostate cancer and will continue on ADT for at least 13 weeks after enrollment. Patient may have been started on ADT at any past time point because patients experience hot flashes throughout ADT treatment * Subjects are experiencing bothersome hot flashes per the study questionnaires * Subjects are capable of giving informed consent. * Willing to comply with all study procedures and be available for the duration of the study * Able to obtain and take an acceptable form of vitamin B6 Exclusion Criteria: * Subjects without a diagnosis of prostate cancer * Subjects already receiving other treatment for hot flashes * Subjects taking selective serotonin reuptake inhibitors (SSRIs) * Subjects are currently taking vitamin supplementation which includes vitamin B6 at doses \> 10 mg
References
Publications (0)
Data not yet available
No reference posted for this study.