Black Cohosh for Host Flashes Due to Androgen Deprivation Therapy

NCT02952742 | Withdrawn Phase 2

• 1 other identifier: MZ2016003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

Study Arms (2)

Black Cohosh Therapy

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Black Cohosh DRUG

Vital Nutrients Black Cohosh Extract

Also known as: Actaea racemosa

Black Cohosh Therapy

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Midwestern Regional Medical Center: lead

MeSH Terms

Conditions

Hot Flashes

Interventions

black cohosh root extract

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Evan Pisick, MD

  Midwestern Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: November 2, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 26, 2017

Record last verified: 2017-12