Clinical trial NCT02952742: Black Cohosh for Host Flashes Due to Androgen Deprivation Therapy
Official title: Black Cohosh (Actaea Racemosa) for Hot Flashes in Prostate Cancer Patients on Androgen Deprivation Therapy: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hot Flashes
Lead sponsor: Midwestern Regional Medical Center
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of hot flashes as calculated from self reported questionnaire
timeFrame: Daily assessments throughout the study (assessed for up to 16 weeks)
Secondary outcomes:
measure: Severity of hot flashes as calculated from self reported questionnaire
timeFrame: Daily assessments throughout the study (assessed for up to 16 weeks)
measure: Quality of life as recorded from self reported questionnaire
timeFrame: Daily assessments throughout the study (assessed for for up to 16 weeks)
measure: Measurement of serum testosterone
timeFrame: From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms)
measure: Measurement of serum aspartate aminotransferase (AST)
timeFrame: From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms)
measure: Measurement of serum alanine aminotransferase (ALT)
timeFrame: From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms)
measure: Measurement of serum bilirubin
timeFrame: From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms)
measure: Measurement of serum Prostate Specific Antigen (PSA)
timeFrame: From the beginning of treatment to the end of the 8-week treatment phase (up to 16 weeks due to cross-over of study arms)
Other outcomes:
Locations:
Study officials:
affiliation: Midwestern Regional Medical Center
name: Evan Pisick, MD
role: PRINCIPAL_INVESTIGATOR
References: