Status:
COMPLETED
Acupuncture in Reducing Muscle and Bone Symptoms in Women Receiving Letrozole, Exemestane, or Anastrozole for Stage 0, Stage I, Stage II, or Stage III Breast Cancer
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Cancer Institute (NCI)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Anxiety Disorder
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
RATIONALE: Acupuncture may help relieve muscle and bone pain caused by aromatase inhibitor therapy, such as letrozole, exemestane, and anastrozole. PURPOSE: This randomized phase II trial is studying...
Detailed Description
OBJECTIVES: Primary * To determine if acupuncture can reduce aromatase inhibitor (AI)-associated musculoskeletal symptom severity, in terms of function and pain, in woman with stage 0-III breast can...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed invasive carcinoma of the breast
- Stage 0-III disease
- Estrogen receptor- and/or progesterone receptor-positive by immunohistochemical staining
- Must be receiving a standard dose of aromatase inhibitor (AI) therapy (i.e., letrozole 2.5 mg once daily, exemestane 25 mg once daily, or anastrozole 1 mg once daily)
- AI therapy has been ongoing for ≥ 1 month and treatment is expected to continue
- AI-associated musculoskeletal symptoms, defined as ≥ 1 of the following:
- Physician-confirmed AI-associated musculoskeletal symptoms
- Patients concurrently enrolled on the clinical trial, "A Multi-Center Randomized Clinical Trial Correlating the Effects of 24 Months of Exemestane or Letrozole on Surrogate Markers of Response with Aromatase Polymorphism," and who have met the referral criteria for a rheumatological evaluation
- No known metastatic (stage IV) breast cancer
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Female
- Menopausal status not specified
- PRIOR CONCURRENT THERAPY:
- No prior acupuncture within past 12 months.
- No other concurrent systemic therapy (i.e., chemotherapy, biologic therapy, or radiotherapy) unless approval is given by the Protocol Chair
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00641303
Start Date
May 1 2008
End Date
November 1 2011
Last Update
May 8 2023
Active Locations (2)
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1
University of Maryland Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410