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| Sponsor: | University of California, San Francisco |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | University of California, San Francisco |
| 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 Drug/Agent Toxicity by Tissue/Organ |
Dietary Supplement: Chinese herbs Drug: cyclophosphamide Drug: doxorubicin hydrochloride Procedure: adjuvant therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| 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 |
| Study Completion Date: | February 2005 |
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 | |
| Study Chair: | Hope S. Rugo, MD | University of California, San Francisco |
More Information
| ClinicalTrials.gov Identifier: | NCT00028964 History of Changes |
| Other Study ID Numbers: | CDR0000069154, UCSF-CRO-97755, UCSF-IND-54870, NCI-G01-2042 |
| Study First Received: | January 4, 2002 |
| Last Updated: | February 20, 2011 |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer recurrent breast cancer drug/agent toxicity by tissue/organ |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Doxorubicin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic |