Clinical trial NCT00028964: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Hope S. Rugo, MD
role: STUDY_CHAIR
References: