| City: |
|
Baltimore |
|
State:
|
|
MD |
| Zip Code: |
|
21231 |
| Conditions: |
|
Anxiety Disorder - Breast Cancer - Depression - Fatigue - Hot Flashes - Pain - Sleep Disorders |
| Purpose: |
|
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 acupuncture to see how well it works 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.
|
| Study summary: |
|
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 cancer.
Secondary
- To assess if acupuncture decreases oral analgesic use in these patients.
- To assess if acupuncture decreases the proportion of patients who change or discontinue
AI therapy.
- To assess if acupuncture improves menopausal symptoms, mood (i.e., depression or
anxiety), sleep quality and sleep disturbance, and overall quality of life of these
patients.
- To assess if acupuncture changes plasma concentrations of estrogens (i.e., E1, E2, and
E1S), cytokine profile, and beta endorphin.
OUTLINE: This is a multicenter study. Patients are stratified according to participation in
the aromatase inhibitor trial, "A Multicenter Randomized Clinical Trial Correlating the
Effects of 24 Months of Exemestane or Letrozole on Surrogate Markers of Response With
Aromatase Polymorphism" (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I (control): Patients receive 8 weekly sessions of sham acupuncture treatment
comprising 20 minutes of a non-penetrating device consisting of a retractable needle
and an adhesive tube on the skin using the Park Sham Device (PSD) in 14 non-acupuncture
points. Patients may receive 4 free acupuncture sessions (not sham) after the 24-week
follow-up visit.
- Arm II (treatment): Patients receive 8 weekly sessions of acupuncture treatment
comprising 20 minutes of needle insertion in 15 acupuncture points including CV 4, CV
6, CV12 and bilateral LI 4, MH 6, GB 34, ST 36, KI 3, BL 65.
Quality of life is assessed periodically to measure changes in symptoms that may be related
to hot flashes and estrogen deprivation (i.e., menopausal symptoms, mood [depression and
anxiety], sleep quality, and overall quality of life using the menopausal symptoms
checklist); the Hot Flash Related Daily Interference Scale (HFRDI) and the Hot Flash Daily
Diary; the Pittsburgh Sleep Quality Index (PSQI); the Center for Epidemiologic Studies
Depression Scale (CESD); the Hospital Anxiety and Depression Scale (HADS-A); and the
EuroQOL.
Patients complete questionnaires including the Health Assessment Questionnaire (HAQ) and
visual analog scales (VAS) to assess both pain and global health status at baseline, after 4
and 8 weeks of acupuncture or sham acupuncture, and at follow-up at 24 weeks. The average
amount of daily oral analgesic usage is assessed at weeks 0, 4, 8, and 24.
Patients undergo blood sample collection periodically for correlative studies. Samples are
analyzed for plasma concentrations of estrogen (i.e., estrone E1, estradiol E2, and estrone
sulfate E1S) via HPLC-MS/MS, level of 35 serum cytokines via addressable laser bead
immunoassay (ALBIA) or classical sandwich ELISA, cytokines and their soluble receptors via
classical sandwich ELISA techniques, and Beta-endorphin via competitive ELISA.
All patients are followed for 24 weeks. Patients in arm I may be followed for an additional
4 weeks if they choose to receive the free acupuncture sessions. |
| Criteria: |
|
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 for any reason
- No other concurrent systemic therapy (i.e., chemotherapy, biologic therapy, or
radiotherapy) unless approval is given by the Protocol Chair |
|
|
|
| Study is available at: |
|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, MD 21231
United States
Primary Contact:
Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce
Email: jhcccro@jhmi.edu
Phone: 410-955-8804 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 22, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|