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

January 25, 2016 updated by: Abramson Cancer Center of the University of Pennsylvania

Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of The University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Procedure: Single Photon Emission Computed Tomography
Undergo single photon emission computed tomographt imaging
Other Names:
  • SPECT imaging, tomography, emission computed, single photon
Procedure: Acupuncture Therapy
Undergo acupuncture
Other Names:
  • Acupuncture
Other: Questionnaire Administration
Ancillary study
Other: Laboratory Biomarker Analysis
Correlative Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
SERT uptake ratios
Hot flash composite score (HFCS)

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 19, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (Estimate)

November 23, 2009

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

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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