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| Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028964 |
Purpose
RATIONALE: Herbs used in traditional Chinese medicine may decrease the side effects of chemotherapy.
PURPOSE: Randomized phase I/II trial to study the effectiveness of herbs used in traditional Chinese medicine in decreasing the side effects of chemotherapy after surgery in women who have stage I, stage II, or early stage III breast cancer.
| Condition | Intervention | Phase |
|
Breast Cancer Cancer-Related Problem/Condition |
Drug: Chinese herbs Drug: cyclophosphamide Drug: doxorubicin hydrochloride Procedure: adjuvant therapy |
Phase I Phase II |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer Herbal Medicine |
| Drug Information available for: | Doxorubicin Doxorubicin hydrochloride Cyclophosphamide |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Randomized, Double Blind, Pacebo-Controlled Study to Assess The Feasibility, Toxicity And Efficacy (Phase I/II) Of A Chinese Herbal Therapy (CHT) For Symptom Management In Women Undergoing Chemotherapy For Stage I/II/III Breast Cancer |
| Study Start Date: | February 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are randomized to one of two treatment arms.
Quality of life is assessed at baseline and on days 3, 24, 45, 66, 84, and 105.
Patients are followed at day 105.
PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |||||
| UCSF Comprehensive Cancer Center | |||||
| San Francisco, California, United States, 94115-1710 | |||||
| UCSF Helen Diller Family Comprehensive Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Hope S. Rugo, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000069154, UCSF-CRO-97755, UCSF-IND-54870, NCI-G01-2042 |
| First Received: | January 4, 2002 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00028964 |
| Health Authority: | United States: Federal Government |
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