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

Abramson Cancer Center at Penn Medicine

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Procedure: Acupuncture Therapy; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Procedure: Single Photon Emission Computed Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT01018108

UPCC 17108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

I

Other group

Description:

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.

Treatment:

Procedure: Single Photon Emission Computed Tomography

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Procedure: Acupuncture Therapy