Visualization of the Effect of Acupuncture on Brain Serotonin in Breast Cancer Survivors

Study Overview
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Brief Summary
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RATIONALE: New imaging procedures, such as single photon emission computed tomography, may help in learning how acupuncture affects serotonin levels in the brain of breast cancer survivors. PURPOSE: This phase I trial is studying the best way to visualize the effect of acupuncture on brain serotonin in breast cancer survivors.

Detailed Description
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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.

Official Title
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Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Single Photon Emission Computed Tomography
* Procedure: Acupuncture Therapy
* Other: Questionnaire Administration
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: I<br>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<br>* Undergo single photon emission computed tomographt imaging<br>* Other names: SPECT imaging, tomography, emission computed, single photon;Procedure: Acupuncture Therapy<br>* Undergo acupuncture<br>* Other names: Acupuncture;Other: Questionnaire Administration<br>* Ancillary study<br>Other: Laboratory Biomarker Analysis<br>* Correlative Study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SERT uptake ratios |  |  | 
| Hot flash composite score (HFCS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flash related daily interference scale (HFRDIS) |  |  | 
| Pittsburgh sleep quality index (PSQI) |  |  | 
| Brief Fatigue Inventory (BFI) |  |  | 
| HADS |  |  | 
| Global assessment scale |  |  | 
| Hot flash frequency and severity |  |  | 
| Acupuncture expectancy scale |  |  | 
| Credibility rating of acupuncture |  |  |