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

NCT01018108 | Completed Phase 1

• 1 other identifier: UPCC 17108
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• SERT uptake ratios

• Hot flash composite score (HFCS)

Secondary Outcomes (8)

• Hot flash related daily interference scale (HFRDIS)

• Pittsburgh sleep quality index (PSQI)

• Brief Fatigue Inventory (BFI)

• HADS

• Global assessment scale

Study Arms (1)

I

OTHER

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; Procedure: Acupuncture Therapy; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis

Interventions

Single Photon Emission Computed Tomography PROCEDURE

Undergo single photon emission computed tomographt imaging

Also known as: SPECT imaging, tomography, emission computed, single photon

I

Acupuncture Therapy PROCEDURE

Undergo acupuncture

Also known as: Acupuncture

I

Questionnaire Administration OTHER

Ancillary study

I

Laboratory Biomarker Analysis OTHER

Correlative Study

I

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Photons; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Elementary Particles; Physical Phenomena; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing; Complementary Therapies; Therapeutics

Study Officials

• Jun Mao, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 23, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

US (1)