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

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• Status: Withdrawn
• Conditions: Hot Flashes
• Intervention / Treatment: Drug: Black Cohosh; Other: Placebo

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 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

Outcome Measure	Measure Description	Time Frame
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.	Daily assessments throughout the study (assessed for up to 16 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Daily assessments throughout the study (assessed for up to 16 weeks)
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.	Daily assessments throughout the study (assessed for for up to 16 weeks)
Measurement of serum testosterone	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)	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)	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	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)	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

• Sponsor: Midwestern Regional Medical Center
• Investigators: Principal Investigator: Evan Pisick, MD, Midwestern Regional Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ANTICIPATED): November 1, 2018
• Study Completion (ANTICIPATED): November 1, 2018

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (ESTIMATE): November 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID Numbers: MZ2016003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED