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A Phase III Double-Blind, Randomized, Placebo-Controlled Crossover Trial Of Black Cohosh In The Management Of Hot Flashes


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Hot Flashes

Thank you

Trial Information

A Phase III Double-Blind, Randomized, Placebo-Controlled Crossover Trial Of Black Cohosh In The Management Of Hot Flashes


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Barbara A. Pockaj, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000301615

NCT ID:

NCT00060320

Start Date:

October 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • Hot Flashes
  • 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
  • Breast Neoplasms
  • Hot Flashes

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Mayo ClinicJacksonville, Florida  32224
Medcenter One Health SystemBismarck, North Dakota  58501
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259