- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01018108
Visualization of the Effect of Acupuncture on Brain Serotonin in Breast Cancer Survivors
Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors
Study Overview
Status
Conditions
Detailed Description
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- History of Stage I, II, or III breast cancer for at least 12 months
- 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:
- Currently on chemotherapy or radiation therapy as adjuvant treatment
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
Undergo single photon emission computed tomographt imaging
Other Names:
Undergo acupuncture
Other Names:
Ancillary study
Correlative Study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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SERT uptake ratios
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Hot flash composite score (HFCS)
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Secondary Outcome Measures
Outcome Measure |
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Hot flash related daily interference scale (HFRDIS)
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Pittsburgh sleep quality index (PSQI)
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Brief Fatigue Inventory (BFI)
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HADS
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Global assessment scale
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Hot flash frequency and severity
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Acupuncture expectancy scale
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Credibility rating of acupuncture
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 17108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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