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

• ClinicalTrials.gov Identifier: NCT00060320
• Recruitment Status: Completed
• First Posted: May 7, 2003
• Last Update Posted: July 13, 2016
• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Alliance for Clinical Trials in Oncology

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Breast Cancer; Hot Flashes	Dietary Supplement: black cohosh; Other: placebo	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• 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
• Study Start Date: October 2003
• Actual Primary Completion Date: June 2006
• Actual Study Completion Date: June 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: black cohost; Patients receive oral black cohosh twice daily for 4 weeks. All patients then cross over to the other arm and receive treatment 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.	Dietary Supplement: black cohosh; Other: placebo
Placebo Comparator: placebo; Patients receive oral placebo twice daily for 4 weeks. All patients then cross over to the other arm and receive treatment 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.	Dietary Supplement: black cohosh; Other: placebo

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Reduction of hot flash score [ Time Frame: Up to 3.5 years ]
2. Quality of life [ Time Frame: Up to 3.5 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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:

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)

Contacts and Locations

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

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Investigators

• Study Chair: Barbara A. Pockaj, MD; Mayo Clinic Hospital

More Information

Publications of Results:

Pockaj BA, Gallagher JG, Loprinzi CL, Stella PJ, Barton DL, Sloan JA, Lavasseur BI, Rao RM, Fitch TR, Rowland KM, Novotny PJ, Flynn PJ, Richelson E, Fauq AH. Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG Trial N01CC1. J Clin Oncol. 2006 Jun 20;24(18):2836-41. doi: 10.1200/JCO.2005.05.4296.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00060320
• Other Study ID Numbers: NCCTG-N01CC; CDR0000301615 ( Registry Identifier: PDQ (Physician Data Query) )
• First Posted: May 7, 2003
• Last Update Posted: July 13, 2016
• Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:

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:

Breast Neoplasms; Hot Flashes; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases