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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00060320
First received: May 6, 2003
Last updated: May 9, 2009
Last verified: August 2004
  Purpose

RATIONALE: The herbal supplement black cohosh may be effective in relieving hot flashes in women.

PURPOSE: Randomized phase III trial to determine the effectiveness of black cohosh in relieving hot flashes in women who have breast cancer or who are at risk of developing breast cancer.


Condition Intervention Phase
Breast Cancer
Hot Flashes
Dietary Supplement: black cohosh
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: A Phase III Double-Blind, Randomized, Placebo-Controlled Crossover Trial Of Black Cohosh In The Management Of Hot Flashes

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2003
Detailed Description:

OBJECTIVES:

  • Compare the efficacy of black cohosh vs placebo in diminishing hot flash activity in women with breast cancer OR a concern about taking hormones because of a fear of breast cancer.
  • Determine whether continued use of this drug by these patients leads to prolonged reduction of the hot flash score with minimal toxic effects.
  • Correlate the reduction of hot flash score with improvement in quality of life and related outcomes in patients treated with this drug.
  • Determine the toxic effects of this drug in these patients.
  • Determine whether abnormal sweating is decreased in patients treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled, crossover study. Patients are stratified according to age (18 to 49 vs 50 and over), current tamoxifen use (yes vs no vs unknown), current raloxifene use (yes vs no vs unknown), current aromatase inhibitor use (yes vs no), duration of hot flash symptoms (less than 9 months vs 9 months or more), and average frequency of hot flashes per day (2-3 vs 4-9 vs 10 or more). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral black cohosh twice daily for 4 weeks.
  • Arm II: Patients receive oral placebo twice daily for 4 weeks. All patients then cross over to the other arm and receive treatment as above for 4 weeks.

After completion of the crossover treatment, all patients may opt to receive open-label black cohosh for an additional 8 weeks.

Patients complete a hot flash diary daily at baseline and during the 8-week double-blind study, and then daily for 8 weeks during optional open-label treatment.

Patients who opt to receive open-label black cohosh are followed at 6 months, 1 year, and 2 years.

PROJECTED ACCRUAL: A total of 110 patients (55 patients per arm) will be accrued for this study within 6-11 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

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:

Biologic therapy

  • Not specified

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

Radiotherapy

  • Not specified

Surgery

  • Not specified

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060320

Locations
United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, North Dakota
Medcenter One Health System
Bismarck, North Dakota, United States, 58501-5505
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Barbara A. Pockaj, MD Mayo Clinic Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00060320     History of Changes
Other Study ID Numbers: CDR0000301615, NCCTG-N01CC
Study First Received: May 6, 2003
Last Updated: May 9, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
hot flashes

Additional relevant MeSH terms:
Hot Flashes
Breast Neoplasms
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014