Visualization of the Effect of Acupuncture on Brain Serotonin in Breast Cancer Survivors
|Breast Cancer||Procedure: Single Photon Emission Computed Tomography Procedure: Acupuncture Therapy Other: Questionnaire Administration Other: Laboratory Biomarker Analysis||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors|
- SERT uptake ratios
- Hot flash composite score (HFCS)
- Hot flash related daily interference scale (HFRDIS)
- Pittsburgh sleep quality index (PSQI)
- Brief Fatigue Inventory (BFI)
- Global assessment scale
- Hot flash frequency and severity
- Acupuncture expectancy scale
- Credibility rating of acupuncture
|Study Start Date:||March 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Patients undergo acupuncture twice weekly for 2 weeks and then once weekly for 6 weeks. Patients undergo single photon emission computed tomography imaging with iodine 123-I ADAM before and after completion of acupuncture.
Procedure: Single Photon Emission Computed Tomography
Undergo single photon emission computed tomographt imaging
Other Name: SPECT imaging, tomography, emission computed, single photonProcedure: Acupuncture Therapy
Other Name: AcupunctureOther: Questionnaire Administration
Ancillary studyOther: Laboratory Biomarker Analysis
I. To determine the feasibility of using [123-I] ADAM Serotonin transporter (SERT) binding as a putative biomarker to visualize the mechanism of effects of acupuncture for hot flashes involving serotonin.
OUTLINE: Patients undergo acupuncture twice weekly for 2 weeks and then once weekly for 6 weeks. Patients undergo single photon emission computed tomography imaging with iodine 123-I ADAM before and after completion of acupuncture.
After completion of study treatment, patients are followed for 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018108
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Jun Mao, MD||Abramson Cancer Center of the University of Pennsylvania|