Clinical trial · Interventional
Visualization of the Effect of Acupuncture on Brain Serotonin in Breast Cancer Survivors
Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors
NCT01018108CI-TRIAL-00020676completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture Therapy | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Single Photon Emission Computed Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- I
- 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.
- interventionNames
- Procedure: Single Photon Emission Computed Tomography
- Procedure: Acupuncture Therapy
- Other: Questionnaire Administration
- Other: Laboratory Biomarker Analysis
Primary outcomes (2)
- measure
- SERT uptake ratios
- measure
- Hot flash composite score (HFCS)
Secondary outcomes (8)
- measure
- Hot flash related daily interference scale (HFRDIS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.