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

This study has been completed.
Sponsor:
Information provided by:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01018108
First received: November 19, 2009
Last updated: April 13, 2011
Last verified: April 2011

November 19, 2009
April 13, 2011
March 2009
December 2010   (final data collection date for primary outcome measure)
  • SERT uptake ratios [ Designated as safety issue: No ]
  • Hot flash composite score (HFCS) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01018108 on ClinicalTrials.gov Archive Site
  • Hot flash related daily interference scale (HFRDIS) [ Designated as safety issue: No ]
  • Pittsburgh sleep quality index (PSQI) [ Designated as safety issue: No ]
  • Brief Fatigue Inventory (BFI) [ Designated as safety issue: No ]
  • HADS [ Designated as safety issue: No ]
  • Global assessment scale [ Designated as safety issue: No ]
  • Hot flash frequency and severity [ Designated as safety issue: No ]
  • Acupuncture expectancy scale [ Designated as safety issue: No ]
  • Credibility rating of acupuncture [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Visualization of the Effect of Acupuncture on Brain Serotonin in Breast Cancer Survivors
Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors

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

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
  • Procedure: Single Photon Emission Computed Tomography
    Undergo single photon emission computed tomographt imaging
    Other Name: SPECT imaging, tomography, emission computed, single photon
  • Procedure: Acupuncture Therapy
    Undergo acupuncture
    Other Name: Acupuncture
  • Other: Questionnaire Administration
    Ancillary study
  • Other: Laboratory Biomarker Analysis
    Correlative Study
I
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.
Interventions:
  • Procedure: Single Photon Emission Computed Tomography
  • Procedure: Acupuncture Therapy
  • Other: Questionnaire Administration
  • Other: Laboratory Biomarker Analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01018108
UPCC 17108
No
Jun James Mao, MD, Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Not Provided
Abramson Cancer Center of the University of Pennsylvania
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP