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

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01018108

Run by

Abramson Cancer Center at Penn Medicine

People needed

7

Starts

2009-03-01

Expected to finish

2010-12-01

Last updated by the study team

2016-01-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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