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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer, Drug/Agent Toxicity by Tissue/Organ

Intervention / Treatment
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* Dietary Supplement: Chinese herbs
* Drug: cyclophosphamide
* Drug: doxorubicin hydrochloride
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Chinese herbs|nan|
|Drug: cyclophosphamide|nan|
|Drug: doxorubicin hydrochloride|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer, drug/agent toxicity by tissue/organ