Visualization of the Effect of Acupuncture on Brain Serotonin in Breast Cancer Survivors
NCT ID: NCT01018108
Last Updated: 2016-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
7 participants
INTERVENTIONAL
2009-03-31
2010-12-31
Brief Summary
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Detailed Description
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OBJECTIVES:
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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I
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.
Single Photon Emission Computed Tomography
Undergo single photon emission computed tomographt imaging
Acupuncture Therapy
Undergo acupuncture
Questionnaire Administration
Ancillary study
Laboratory Biomarker Analysis
Correlative Study
Interventions
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Single Photon Emission Computed Tomography
Undergo single photon emission computed tomographt imaging
Acupuncture Therapy
Undergo acupuncture
Questionnaire Administration
Ancillary study
Laboratory Biomarker Analysis
Correlative Study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have been seen by an oncologist within the previous 6-month period and determined to be free of disease by clinical examination and history
* Have been receiving endocrine therapy (tamoxifen or aromatase inhibitors for at least four weeks)
* Experienced hot flashes with a hot flash composite score of 5 or greater per day
* Hot flashes have been present for at least a month before study entry
Exclusion Criteria
* Started with hormonal therapies such as tamoxifen or aromatase inhibitors within the last 4 weeks; or plan to change or terminate hormonal therapies in the next 14 weeks
* Any history of use of psychotropic medication such as SSRI use for the past 6 months
* Any past use of centrally acting medications such as clonidine for the past 6 months
* Any past diagnosis of a Major Depressive Episode within the last 6 months
* Any allergy to iodine or shell-fish or radio-nuclear materials
* Current use of estrogen and/or progestin
* Pregnancy
* Breast feeding
* Women of child-bearing potential NOT willing to use a medically acceptable form of contraception
* Current use of any anti-convulsant such as gabapentin
* History of cerebral infarction (including lacunar infarct with symptoms \>= 24 hours duration)
* History of Binswanger's disease (or a history of hypertensive encephalopathy)
* History of intracranial hemorrhage
* History of head trauma with loss of consciousness
* History of encephalitis
* History of extended exposure to known neurotoxin (e.g., cyanide, carbon monoxide)
* Uncontrolled metabolic disorder (e.g., thyroid disease, diabetes mellitus)
* History of normal pressure hydrocephalus
* History of Parkinson's or other basal ganglia disease
* History of substance abuse in the previous 6 months
18 Years
FEMALE
No
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Principal Investigators
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Jun Mao, MD
Role: PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Locations
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Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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UPCC 17108
Identifier Type: -
Identifier Source: org_study_id
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