Clinical trial · Interventional
Black Cohosh for Host Flashes Due to Androgen Deprivation Therapy
Black Cohosh (Actaea Racemosa) for Hot Flashes in Prostate Cancer Patients on Androgen Deprivation Therapy: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding support
Summary
Brief summary (as posted)
This is a randomized, placebo-controlled crossover study. Participants will be actively participating in the study for 6 months, and enrolled in the study for up to 1 year. During the first phase of the study, the participants will be randomized into either the placebo group or treatment group for 8 weeks following 1 week of baseline data collection (no treatment). Following this first phase, a no-treatment washout period of at least 3 weeks will be implemented for all participants. After the washout period, the randomized groups will switch from treatment to placebo group, or placebo to treatment group for an additional 8 week period. Hot flash frequency and severity will be documented using a daily hot flash diary and calculated using the Hot Flash Score questionnaire. The impact on quality of life will be documented by weekly Hot Flash Related Daily Interference Scale (HFRDIS) questionnaires.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Black Cohosh | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Black Cohosh Therapy
- description
- Black Cohosh will be provided in 250mg capsules. Subjects will take 2 capsules by mouth daily for a total daily dose of 500 mg. Subject's will remain on this study arm for 8 weeks.
- interventionNames
- Drug: Black Cohosh
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Subjects will take 2 capsules, identical to the Black Cohosh capsules, by mouth each. Subject's will remain on this study arm for 8 weeks.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Frequency of hot flashes as calculated from self reported questionnaire
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Able to understand English or be wiling to use a trained interpreter * Diagnosis of prostate cancer * Receiving either Leuprolide or Degarelix,for prostate cancer treatment * Currently experiencing a minimum of 3 self-reported hot flashes within a 24 hour period * Eastern Cooperative Oncology Group (ECOG) performance status score \< 2 * Life expectancy \>3 months. * No grade 3 or higher toxicity from prior cancer therapies unless judged by the principal investigator to be clinically irrelevant to study procedures * At least four (4) weeks following prior major surgery * Serum testosterone concentration below castrate level (\< 30 ng/dL) at time of recruitment * Willing to provide written informed consent for participation in the study Exclusion Criteria: * Concurrent severe illness effecting ECOG performance status or life expectancy as determined by the principal investigator * Hormone refractory patients. Patients taking Enzalutamide or Abiraterone. * Active infection * Psychiatric illness or social situation that would limit safety and compliance with study requirements * Currently taking any pharmaceutical medications that have potential interactions with black cohosh as determined by the principal investigator * Currently taking any supplements that have potential interactions with black cohosh as determined by the principal investigator * Currently receiving any treatment for hot flashes or planning to initiate any treatment for hot flashes other than with study supplementation * ALT, AST, or Bilirubin \> 2 times their normal laboratory values in the past 3 months * Inability to complete the informed consent process or adhere to the protocol treatment plan.
References
Publications (0)
Data not yet available