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

Primary Purpose

Breast Cancer, Hot Flashes

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
black cohosh
placebo
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • CCOP - Mayo Clinic Scottsdale Oncology Program
  • Mayo Clinic
  • CCOP - Carle Cancer Center
  • CCOP - Iowa Oncology Research Association
  • Siouxland Hematology-Oncology
  • CCOP - Wichita
  • CCOP - Michigan Cancer Research Consortium
  • Mayo Clinic Cancer Center
  • CCOP - Metro-Minnesota
  • CCOP - Missouri Valley Cancer Consortium
  • Medcenter One Health System
  • CCOP - Merit Care Hospital
  • CCOP - Sioux Community Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

black cohost

placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hot flash activity

Secondary Outcome Measures

Reduction of hot flash score
Quality of life

Full Information

First Posted
May 6, 2003
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00060320
Brief Title
Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer
Official Title
A Phase III Double-Blind, Randomized, Placebo-Controlled Crossover Trial Of Black Cohosh In The Management Of Hot Flashes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Hot Flashes
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
black cohost
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
black cohosh
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Hot flash activity
Time Frame
Up to 3.5 years
Secondary Outcome Measure Information:
Title
Reduction of hot flash score
Time Frame
Up to 3.5 years
Title
Quality of life
Time Frame
Up to 3.5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara A. Pockaj, MD
Organizational Affiliation
Mayo Clinic Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Mayo Clinic Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
Siouxland Hematology-Oncology
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Medcenter One Health System
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501-5505
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16782922
Citation
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.
Results Reference
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Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer

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