Black Cohosh for Host Flashes Due to Androgen Deprivation Therapy

December 21, 2017 updated by: Evan Pisick, Midwestern Regional Medical Center

Black Cohosh (Actaea Racemosa) for Hot Flashes in Prostate Cancer Patients on Androgen Deprivation Therapy: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Black Cohosh Therapy
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.
Drug: Black Cohosh
Vital Nutrients Black Cohosh Extract
Other Names:
  • Actaea racemosa
PLACEBO_COMPARATOR: Placebo
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.
Other: Placebo
Inactive comparator resembling the Black Cohosh formulation in appearance. Ingredients include: cellulose; caramel color; powdered yellow dye; and powdered red dye.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of hot flashes as calculated from self reported questionnaire
Time Frame: Daily assessments throughout the study (assessed for up to 16 weeks)
Subjects will record the number and timing of their on the Hot Flash Related Daily Interference (HFRDIS) questionnaire each week during the study.
Daily assessments throughout the study (assessed for up to 16 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity of hot flashes as calculated from self reported questionnaire
Time Frame: Daily assessments throughout the study (assessed for up to 16 weeks)
Subjects will record the intensity of their hot flashes on the Hot Flash Related Daily Interference (HFRDIS) questionnaire each day during the study.
Daily assessments throughout the study (assessed for up to 16 weeks)
Quality of life as recorded from self reported questionnaire
Time Frame: Daily assessments throughout the study (assessed for for up to 16 weeks)
Subjects will answer questions regarding the impact of their hot flashes on the Hot Flash Related Daily Interference (HFRDIS) questionnaire each day during the study.
Daily assessments throughout the study (assessed for for up to 16 weeks)
Measurement of serum testosterone
Time Frame: 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)
The effect of Black Cohosh on serum testosterone will be measured at the end of each 8-week treatment cycle.
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)
Measurement of serum aspartate aminotransferase (AST)
Time Frame: 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)
The effect of Black Cohosh on AST will be measured at the end of each 8-week treatment cycle.
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)
Measurement of serum alanine aminotransferase (ALT)
Time Frame: 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)
The effect of Black Cohosh on serum ALT will be measured at the end of each 8-week treatment cycle.
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)
Measurement of serum bilirubin
Time Frame: 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)
The effect of Black Cohosh on serum bilirubin will be measured at the end of each 8-week treatment cycle.
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)
Measurement of serum Prostate Specific Antigen (PSA)
Time Frame: 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)
The effect of Black Cohosh on serum PSA will be measured at the end of each 8-week treatment cycle.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Midwestern Regional Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Evan Pisick, MD, Midwestern Regional Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MZ2016003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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