search
Back to results

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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Single Photon Emission Computed Tomography
Acupuncture Therapy
Questionnaire Administration
Laboratory Biomarker Analysis
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

I

Arm Description

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.

Outcomes

Primary Outcome Measures

SERT uptake ratios
Hot flash composite score (HFCS)

Secondary Outcome Measures

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

Full Information

First Posted
November 19, 2009
Last Updated
January 25, 2016
Sponsor
Abramson Cancer Center at Penn Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT01018108
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Single Photon Emission Computed Tomography
Other Intervention Name(s)
SPECT imaging, tomography, emission computed, single photon
Intervention Description
Undergo single photon emission computed tomographt imaging
Intervention Type
Procedure
Intervention Name(s)
Acupuncture Therapy
Other Intervention Name(s)
Acupuncture
Intervention Description
Undergo acupuncture
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary study
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative Study
Primary Outcome Measure Information:
Title
SERT uptake ratios
Title
Hot flash composite score (HFCS)
Secondary Outcome Measure Information:
Title
Hot flash related daily interference scale (HFRDIS)
Title
Pittsburgh sleep quality index (PSQI)
Title
Brief Fatigue Inventory (BFI)
Title
HADS
Title
Global assessment scale
Title
Hot flash frequency and severity
Title
Acupuncture expectancy scale
Title
Credibility rating of acupuncture

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs