Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Vermont
About this trial
This study is for men with prostate cancer who are experiencing hot flashes due to treatments that lower testosterone. Hot flashes can affect your quality of life and make it harder for patients to continue their treatment, so researchers want to find a better way to manage them. The study is testing a drug called fezolinetant, which might help reduce hot flashes without using hormones. Fezolinetant is a drug that is currently approved for the treatment of hot flashes in menopausal women.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Fezolinetant
DrugParticipants will receive fezolinetant for 28 days at FDA approved dosing and schedule of 45 mg po (per os/by mouth) once daily for treatment of hot flashes in menopausal women.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: fezolinetant treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Reduction in Hot Flash Score
Assess the effect of fezolinetant 45 mg daily on the 7-day period participant-reported Hot Flash Score (HFS) at 4 weeks relative to baseline. The HFS sums the number of hot flashes multiplied by the intensity of each hot flash to estimate the overall hot flash burden during a 24 hour period, averaged over a 7 day period.
Time frame
28 daySecondary outcomes
1
To characterize the safety and adverse event profile of fezolinetant in the study population.
To characterize the safety and adverse event profile of fezolinetant in the study population by monitoring adverse events.
Time frame
28 day2
Measure Compliance of Fezolinetant Therapy in Men
Compliance will be assessed based on a combination of the Hot Flash diary (HFD) responses, the weekly phone calls during the Treatment Phase, and the participant visit at the end of the Treatment Phase.
Time frame
28 day3
Hot Flash Frequency
To assess the effect of fezolinetant on participant-reported Hot Flash Frequency (HFF) at 4 weeks relative to baseline.
Time frame
28 day4
Patient Reported Quality of Life
To measure the impact of fezolinetant treatment participant-reported quality of life and hot flash interference, as measured by the Hot Flash Related Daily Interference Scale (HFRDIS) after 4 weeks compared to baseline. The HFRDIS is a 10-item instrument developed and validated to assess the interference of hot flashes on multiple specific important quality of life dimensions in this patient population.
Time frame
28 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Vermont
Lead sponsor
University of Vermont Medical Center
Sponsor institution
Source ClinicalTrials.gov