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
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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Hope S. Rugo, MD
Study Chair
University of California, San Francisco
United States: Federal Government
CDR0000069154
NCT00028964
February 2001
February 2005
Name | Location |
---|---|
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |