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Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors

Phase 1
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors

Detailed Description


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.

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

- Current use of any anti-convulsant such as gabapentin

- History of cerebral infarction (including lacunar infarct with symptoms >= 24 hours

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

SERT uptake ratios

Safety Issue:



United States: Institutional Review Board

Study ID:

UPCC 17108



Start Date:

March 2009

Completion Date:

December 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283