Combination Chemotherapy After Surgery With or Without Chinese Herbal Therapy to Treat Symptoms in Women With Breast Cancer

Phase 1

Completed

• Conditions: Breast Cancer; Drug/Agent Toxicity by Tissue/Organ

• Registration Number: NCT00028964
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

OBJECTIVES:

* Determine the toxic effects and safety of chinese herbal therapy (CHT) when administered for toxicity attenuation in combination with adjuvant doxorubicin and cyclophosphamide in women with stage I, II, or early stage III breast cancer.

* Determine patient compliance and the feasibility of using CHT by daily treatment calendars, weekly symptom inventories, and quality of life and mood state questionnaires completed by these patients.

* Determine patient preferences and concerns about CHT.

* Determine, preliminarily, the efficacy of CHT in ameliorating the toxic effects/side effects of adjuvant chemotherapy with doxorubicin and cyclophosphamide, in terms of the incidence and severity of adverse events, in these patients.

OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive adjuvant doxorubicin IV and cyclophosphamide IV over 1 hour on days 0, 21, 42, and 63. Patients also receive oral chinese herbal therapy three times daily on days -10 to 105.

* Arm II: Patients receive adjuvant chemotherapy as in arm I and oral placebo three times daily on days -10 to 105.

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.

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2002-01-04
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Completion: 2005-02
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-20
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States