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

Primary Purpose

Breast Cancer, Drug/Agent Toxicity by Tissue/Organ

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Chinese herbs
cyclophosphamide
doxorubicin hydrochloride
adjuvant therapy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer, drug/agent toxicity by tissue/organ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 4, 2002
Last Updated
February 20, 2011
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00028964
Brief Title
Combination Chemotherapy After Surgery With or Without Chinese Herbal Therapy to Treat Symptoms in Women With Breast Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Drug/Agent Toxicity by Tissue/Organ
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer, drug/agent toxicity by tissue/organ

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Chinese herbs
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hope S. Rugo, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115-1710
Country
United States

12. IPD Sharing Statement

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

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