Black Cohosh for Host Flashes Due to Androgen Deprivation Therapy

NCT ID: NCT02952742

Last Updated: 2017-12-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-11-30

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.

Conditions

Hot Flashes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Black Cohosh

Intervention Type: DRUG

Vital Nutrients Black Cohosh Extract

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Black Cohosh

Vital Nutrients Black Cohosh Extract

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Actaea racemosa

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Midwestern Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Evan Pisick

Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evan Pisick, MD

Role: PRINCIPAL_INVESTIGATOR

Midwestern Regional Medical Center

Other Identifiers

MZ2016003

Identifier Type: -

Identifier Source: org_study_id