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

This study has been completed.

Sponsor:

Information provided by:

Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01018108

First received: November 19, 2009

Last updated: April 13, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	November 19, 2009
Last Updated Date	April 13, 2011
Start Date ^ICMJE	March 2009
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 19, 2009)	SERT uptake ratios [ Designated as safety issue: No ] Hot flash composite score (HFCS) [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01018108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 19, 2009)	Hot flash related daily interference scale (HFRDIS) [ Designated as safety issue: No ] Pittsburgh sleep quality index (PSQI) [ Designated as safety issue: No ] Brief Fatigue Inventory (BFI) [ Designated as safety issue: No ] HADS [ Designated as safety issue: No ] Global assessment scale [ Designated as safety issue: No ] Hot flash frequency and severity [ Designated as safety issue: No ] Acupuncture expectancy scale [ Designated as safety issue: No ] Credibility rating of acupuncture [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Visualization of the Effect of Acupuncture on Brain Serotonin in Breast Cancer Survivors
Official Title ^ICMJE	Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors
Brief Summary	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	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 ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Breast Cancer
Intervention ^ICMJE	Procedure: Single Photon Emission Computed Tomography Undergo single photon emission computed tomographt imaging Other Name: SPECT imaging, tomography, emission computed, single photon Procedure: Acupuncture Therapy Undergo acupuncture Other Name: Acupuncture Other: Questionnaire Administration Ancillary study Other: Laboratory Biomarker Analysis Correlative Study
Study Arm (s)	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. Interventions: Procedure: Single Photon Emission Computed Tomography Procedure: Acupuncture Therapy Other: Questionnaire Administration Other: Laboratory Biomarker Analysis
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	7
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01018108
Other Study ID Numbers ^ICMJE	UPCC 17108
Has Data Monitoring Committee	No
Responsible Party	Jun James Mao, MD, Abramson Cancer Center of the University of Pennsylvania
Study Sponsor ^ICMJE	Abramson Cancer Center of the University of Pennsylvania
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Abramson Cancer Center of the University of Pennsylvania
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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