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Trial record 2 of 22 for:    black cohosh

Black Cohosh for Host Flashes Due to Androgen Deprivation Therapy

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ClinicalTrials.gov Identifier: NCT02952742
Recruitment Status : Withdrawn (Lack of funding support)
First Posted : November 2, 2016
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Evan Pisick, Midwestern Regional Medical Center

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.

Condition or disease Intervention/treatment Phase
Hot Flashes Drug: Black Cohosh Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952742


Sponsors and Collaborators
Midwestern Regional Medical Center
Investigators
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Principal Investigator: Evan Pisick, MD Midwestern Regional Medical Center

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Responsible Party: Evan Pisick, Medical Oncologist, Midwestern Regional Medical Center
ClinicalTrials.gov Identifier: NCT02952742     History of Changes
Other Study ID Numbers: MZ2016003
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hot Flashes
Signs and Symptoms
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs