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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: Single Photon Emission Computed Tomography
Procedure: Acupuncture Therapy
Other: Questionnaire Administration
Other: Laboratory Biomarker Analysis
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • SERT uptake ratios [ Designated as safety issue: No ]
  • Hot flash composite score (HFCS) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 7
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018108

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Jun James Mao, MD, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01018108     History of Changes
Other Study ID Numbers: UPCC 17108
Study First Received: November 19, 2009
Last Updated: April 13, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 21, 2014