Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT00060320
• Date of registration: 06/05/2003
• Prospective Registration: Yes
• Primary sponsor: Alliance for Clinical Trials in Oncology
• Public title: Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer
• Scientific title: A Phase III Double-Blind, Randomized, Placebo-Controlled Crossover Trial Of Black Cohosh In The Management Of Hot Flashes
• Date of first enrolment: October 2003
• Target sample size: 132
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00060320
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Barbara A. Pockaj, MD
• Affiliation: Mayo Clinic Hospital

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- History of breast cancer OR concern about taking hormones because of fear of breast
cancer

- No current active disease

- No current evidence of malignant disease

- Bothersome hot flashes

- Patient-reported occurrence at least 14 times per week and of sufficient
severity to make the patient desire therapeutic intervention

- Hormone receptor status:

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex

- Female

Performance status

- ECOG 0-1

Life expectancy

- At least 6 months

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to complete questionnaires alone or with assistance

PRIOR CONCURRENT THERAPY:

Chemotherapy

- More than 4 weeks since prior antineoplastic chemotherapy

- No concurrent antineoplastic chemotherapy during the double-blind portion of the
study

Endocrine therapy

- More than 4 weeks since prior androgens, estrogens, or progestational agents

- More than 2 weeks since prior dehydroepiandrosterone (DHEA) for hot flashes

- No concurrent androgens, estrogens, or progestational agents during the double-blind
portion of the study

- No concurrent DHEA for hot flashes

- Concurrent tamoxifen, raloxifene, or an aromatase inhibitor is allowed provided the
patient started the drug at least 4 weeks prior to study entry and plans to continue
the drug throughout the double-blind portion of the study Other

- More than 2 weeks since prior antidepressants

- More than 2 weeks since other prior agents for treating hot flashes (e.g., clonidine
or Bellergal-s)

- No prior black cohosh

- No concurrent antidepressants during the double-blind portion of the study

- No other concurrent agents for treating hot flashes (e.g., clonidine or Bellergal-s)

- Concurrent vitamin E and/or soy allowed provided patient is on a stable dose for
at least 1 month prior to study entry and plans to continue the same dose
throughout study duration

- No concurrent oral herbal therapies or therapeutic herbal teas or tinctures except
beverage teas (e.g., chamomile, ginger, peppermint, lemongrass, and fruit-based tea)



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Hot Flashes

Intervention(s)

Dietary Supplement: black cohosh

Other: placebo

Primary Outcome(s)

Hot flash activity [Time Frame: Up to 3.5 years]

Secondary Outcome(s)

Quality of life [Time Frame: Up to 3.5 years]

Reduction of hot flash score [Time Frame: Up to 3.5 years]

Secondary ID(s)

CDR0000301615

NCCTG-N01CC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)