Hot FlashesNCT03580499
Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
A study testing Vitamin B6 and Questionnaire Administration in people with Hot Flashes and Prostate Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Hot Flashes, Prostate Carcinoma
- What is being tested?
- Vitamin B6 and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2018to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Pilot Study of the Effects of Vitamin B6 on Hot Flash Symptoms in Prostate Cancer Patients
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the effect of Vitamin B6 in improves the frequency or severity of hot flashes in prostate cancer patients receiving antiandrogen therapy (androgen deprivation therapy [ADT]).
OUTLINE:
Participants receive vitamin B6 orally (PO) daily for 12 weeks.
- Conditions
- Hot Flashes, Prostate Carcinoma
- Being tested
- Vitamin B6, Questionnaire Administration
- Medical subject headings
- Hot Flashes, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B6Dietary supplement
Also called 8059-24-3, VIT B6, Vitamin B-6, Vitamin B 6
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (vitamin B6) | Experimental | Participants receive vitamin B6 PO daily for 12 weeks. Receives: Dietary Supplement: Vitamin B6; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)
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.
Measured: Baseline to 8 weeks
Secondary outcomes (1)
Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)
The same approach will be used for the secondary analysis of 12-week post-treatment responses in comparison to the pre-treatment responses.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start13 Sep 2018
- Primary completion30 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Costas Lallas, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580499
- Sponsor's protocol ID
- 18D.273
- Other IDs
- JT 12134
- Status last verified
- Oct 2025
- First submitted
- 29 Jun 2018
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effects of Vitamin B6 on Hot Flash Symptoms in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT03580499
- Acronym / sponsor ID
- 18D.273
- Conditions
- Hot Flashes, Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the effect of Vitamin B6 in improves the frequency or severity of hot flashes in prostate cancer patients receiving antiandrogen therapy (androgen deprivation therapy [ADT]).
OUTLINE:
Participants receive vitamin B6 orally (PO) daily for 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (vitamin B6) | Experimental | Dietary Supplement: Vitamin B6, Other: Questionnaire AdministrationParticipants receive vitamin B6 PO daily for 12 weeks. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin B6Also: 8059-24-3, VIT B6, Vitamin B-6, Vitamin B 6Given PO | Dietary supplement | Supportive Care (vitamin B6) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (vitamin B6) |
Primary outcome
Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)
Time frame: Baseline to 8 weeks
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.
1 secondary outcome
Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Thomas Jefferson University HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Costas Lallas, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B6 and Questionnaire Administration in people with Hot Flashes and Prostate Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe) (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.