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
18 Years
N/A
Female
Breast Cancer, Drug/Agent Toxicity by Tissue/Organ
Trial Information
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed stage I, II, or early stage III breast cancer for which
adjuvant doxorubicin and cyclophosphamide is recommended
- No metastatic disease
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Over 18
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Karnofsky 80-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Hemoglobin at least 9.0 g/dL
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST no greater than 2 times normal
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No evidence of acute ischemic cardiac disease on ECG
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of multiple severe food or medicine allergies or sensitivities
- No medical or psychological condition that would preclude study participation
- No severe concurrent illness
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
Chemotherapy:
- See Disease Characteristics
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy
Radiotherapy:
- At least 3 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- At least 3 weeks since prior investigational agents
- At least 3 weeks since prior herbal therapy
- No other concurrent investigational agents
- No other concurrent herbal therapy or alternative medicine
- Concurrent acupuncture allowed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Principal Investigator
Hope S. Rugo, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Federal Government
Study ID:
CDR0000069154
NCT ID:
NCT00028964
Start Date:
February 2001
Completion Date:
February 2005
Related Keywords:
- Breast Cancer
- Drug/Agent Toxicity by Tissue/Organ
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- drug/agent toxicity by tissue/organ
- Breast Neoplasms
Name | Location |
|---|---|
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
