Visualization of the Effect of Acupuncture on Brain Serotonin in Breast Cancer Survivors
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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 |
- SERT uptake ratios [ Designated as safety issue: No ]
- Hot flash composite score (HFCS) [ Designated as safety issue: No ]
- 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 |
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| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Serotonin |
Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013