Full Text View
Tabular View
No Study Results Posted
Related Studies
Combination Chemotherapy After Surgery With or Without Chinese Herbal Therapy to Treat Symptoms in Women With Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: January 4, 2002   Last Updated: May 9, 2009   History of Changes
Sponsor: UCSF Helen Diller Family Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028964
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug/Agent Toxicity by Tissue/Organ
Dietary Supplement: Chinese herbs
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Procedure: adjuvant therapy
Phase I
Phase II

Study Type: Interventional
Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028964

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115-1710
Sponsors and Collaborators
UCSF Helen Diller Family Comprehensive Cancer Center
Investigators
Study Chair: Hope S. Rugo, MD UCSF Helen Diller Family Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069154, UCSF-CRO-97755, UCSF-IND-54870, NCI-G01-2042
Study First Received: January 4, 2002
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00028964     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
recurrent breast cancer
drug/agent toxicity by tissue/organ

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Cyclophosphamide
Antibiotics, Antineoplastic
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Breast Diseases

ClinicalTrials.gov processed this record on November 09, 2009