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

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Single Photon Emission Computed Tomography; Procedure: Acupuncture Therapy; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis

• Registration Number: NCT01018108
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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.

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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-23
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-25
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I	Laboratory Biomarker Analysis	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.
I	Questionnaire Administration	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.
I	Single Photon Emission Computed Tomography	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.
I	Acupuncture Therapy	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.

Primary Outcome Measures

Name	Time	Method
SERT uptake ratios
Hot flash composite score (HFCS)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States