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

Abramson Cancer Center at Penn Medicine logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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