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

Black Cohosh for Host Flashes Due to Androgen Deprivation Therapy

Sponsors

Lead sponsor: Midwestern Regional Medical Center

Source 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.

Overall Status Withdrawn
Start Date November 2016
Completion Date November 2018
Primary Completion Date November 2018
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Frequency of hot flashes as calculated from self reported questionnaire Daily assessments throughout the study (assessed for up to 16 weeks)
Secondary Outcome
Measure Time Frame
Severity of hot flashes as calculated from self reported questionnaire Daily assessments throughout the study (assessed for up to 16 weeks)
Quality of life as recorded from self reported questionnaire Daily assessments throughout the study (assessed for for up to 16 weeks)
Measurement of serum testosterone 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) 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) 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 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) 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)
Condition
Intervention

Intervention type: Drug

Intervention name: Black Cohosh

Description: Vital Nutrients Black Cohosh Extract

Arm group label: Black Cohosh Therapy

Other name: Actaea racemosa

Intervention type: Other

Intervention name: Placebo

Description: Inactive comparator resembling the Black Cohosh formulation in appearance. Ingredients include: cellulose; caramel color; powdered yellow dye; and powdered red dye.

Arm group label: Placebo

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.

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Evan Pisick, MD Principal Investigator Midwestern Regional Medical Center
Verification Date

December 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Midwestern Regional Medical Center

Investigator full name: Evan Pisick

Investigator title: Medical Oncologist

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Black Cohosh Therapy

Arm group type: Experimental

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 group label: Placebo

Arm group type: Placebo Comparator

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.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov