NCT00028964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2001

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

February 23, 2011

Status Verified

February 1, 2011

First QC Date

January 4, 2002

Last Update Submit

February 20, 2011

Conditions

Breast CancerDrug/Agent Toxicity by Tissue/Organ

Keywords

stage I breast cancerstage II breast cancerstage IIIA breast cancerrecurrent breast cancerdrug/agent toxicity by tissue/organ

Interventions

Chinese herbsDIETARY_SUPPLEMENT
cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
adjuvant therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115-1710, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsDrug-Related Side Effects and Adverse Reactions

Interventions

CyclophosphamideDoxorubicinChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Hope S. Rugo, MD

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2002

First Posted

January 27, 2003

Study Start

February 1, 2001

Study Completion

February 1, 2005

Last Updated

February 23, 2011

Record last verified: 2011-02

Locations

US(1)