Back to resultsBlack Cohosh for Host Flashes Due to Androgen Deprivation Therapy
Primary Purpose
Hot Flashes
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Black Cohosh
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Black Cohosh Therapy
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
Frequency of hot flashes as calculated from self reported questionnaire
Subjects will record the number and timing of their on the Hot Flash Related Daily Interference (HFRDIS) questionnaire each week during the study.
Secondary Outcome Measures
Severity of hot flashes as calculated from self reported questionnaire
Subjects will record the intensity of their hot flashes on the Hot Flash Related Daily Interference (HFRDIS) questionnaire each day during the study.
Quality of life as recorded from self reported questionnaire
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.
Measurement of serum testosterone
The effect of Black Cohosh on serum testosterone will be measured at the end of each 8-week treatment cycle.
Measurement of serum aspartate aminotransferase (AST)
The effect of Black Cohosh on AST will be measured at the end of each 8-week treatment cycle.
Measurement of serum alanine aminotransferase (ALT)
The effect of Black Cohosh on serum ALT will be measured at the end of each 8-week treatment cycle.
Measurement of serum bilirubin
The effect of Black Cohosh on serum bilirubin will be measured at the end of each 8-week treatment cycle.
Measurement of serum Prostate Specific Antigen (PSA)
The effect of Black Cohosh on serum PSA will be measured at the end of each 8-week treatment cycle.
Full Information
NCT ID
NCT02952742
First Posted
March 15, 2016
Last Updated
December 21, 2017
Sponsor
Midwestern Regional Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02952742
Brief Title
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
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding support
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Midwestern Regional Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Black Cohosh Therapy
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Black Cohosh
Other Intervention Name(s)
Actaea racemosa
Intervention Description
Vital Nutrients Black Cohosh Extract
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Inactive comparator resembling the Black Cohosh formulation in appearance. Ingredients include: cellulose; caramel color; powdered yellow dye; and powdered red dye.
Primary Outcome Measure Information:
Title
Frequency of hot flashes as calculated from self reported questionnaire
Description
Subjects will record the number and timing of their on the Hot Flash Related Daily Interference (HFRDIS) questionnaire each week during the study.
Time Frame
Daily assessments throughout the study (assessed for up to 16 weeks)
Secondary Outcome Measure Information:
Title
Severity of hot flashes as calculated from self reported questionnaire
Description
Subjects will record the intensity of their hot flashes on the Hot Flash Related Daily Interference (HFRDIS) questionnaire each day during the study.
Time Frame
Daily assessments throughout the study (assessed for up to 16 weeks)
Title
Quality of life as recorded from self reported questionnaire
Description
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.
Time Frame
Daily assessments throughout the study (assessed for for up to 16 weeks)
Title
Measurement of serum testosterone
Description
The effect of Black Cohosh on serum testosterone will be measured at the end of each 8-week treatment cycle.
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)
Title
Measurement of serum aspartate aminotransferase (AST)
Description
The effect of Black Cohosh on AST will be measured at the end of each 8-week treatment cycle.
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)
Title
Measurement of serum alanine aminotransferase (ALT)
Description
The effect of Black Cohosh on serum ALT will be measured at the end of each 8-week treatment cycle.
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)
Title
Measurement of serum bilirubin
Description
The effect of Black Cohosh on serum bilirubin will be measured at the end of each 8-week treatment cycle.
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)
Title
Measurement of serum Prostate Specific Antigen (PSA)
Description
The effect of Black Cohosh on serum PSA will be measured at the end of each 8-week treatment cycle.
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)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Pisick, MD
Organizational Affiliation
Midwestern Regional Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Black Cohosh for Host Flashes Due to Androgen Deprivation Therapy
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