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

Breast Cancer Clinical Trial

Official title:

Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018108
• Other study ID #: UPCC 17108
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2009
• Last updated: January 25, 2016
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2016
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Single Photon Emission Computed Tomography
Undergo single photon emission computed tomographt imaging
• Acupuncture Therapy
Undergo acupuncture

Other:
• Questionnaire Administration
Ancillary study
• Laboratory Biomarker Analysis
Correlative Study

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SERT uptake ratios			No
Primary	Hot flash composite score (HFCS)			No
Secondary	Hot flash related daily interference scale (HFRDIS)			No
Secondary	Pittsburgh sleep quality index (PSQI)			No
Secondary	Brief Fatigue Inventory (BFI)			No
Secondary	HADS			No
Secondary	Global assessment scale			No
Secondary	Hot flash frequency and severity			No
Secondary	Acupuncture expectancy scale			No
Secondary	Credibility rating of acupuncture			No