Clinical trial · Interventional
Black Cohosh in Treating Hot Flashes in Women Who Have or Who Are At Risk of Developing Breast Cancer
A Phase III Double-Blind, Randomized, Placebo-Controlled Crossover Trial Of Black Cohosh In The Management Of Hot Flashes
NCT00060320CI-TRIAL-00023005completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hot Flashes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| black cohosh | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- black cohost
- 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.
- interventionNames
- Dietary Supplement: black cohosh
- Other: placebo
- type
- PLACEBO_COMPARATOR
- label
- placebo
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- RESULTPockaj 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. PMID 16782922