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| Sponsor: | UCSF Helen Diller Family Comprehensive Cancer Center |
|---|---|
| Collaborator: |
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 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: | 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 | |
| Study Chair: | Hope S. Rugo, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000069154, UCSF-CRO-97755, UCSF-IND-54870, NCI-G01-2042 |
| Study First Received: | January 4, 2002 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00028964 History of Changes |
| 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 |
|
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Antibiotics, Antineoplastic Immunosuppressive Agents Doxorubicin |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |