Clinical trial NCT01018108: Visualization of the Effect of Acupuncture on Brain Serotonin in Breast Cancer Survivors
Official title: Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2009-11-23
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: SERT uptake ratios
measure: Hot flash composite score (HFCS)
Secondary outcomes:
measure: Hot flash related daily interference scale (HFRDIS)
measure: Pittsburgh sleep quality index (PSQI)
measure: Brief Fatigue Inventory (BFI)
measure: HADS
measure: Global assessment scale
measure: Hot flash frequency and severity
measure: Acupuncture expectancy scale
measure: Credibility rating of acupuncture
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Jun Mao, MD
role: PRINCIPAL_INVESTIGATOR
References: