Breast CancerPhase 1NCT01018108
Visualization of the Effect of Acupuncture on Brain Serotonin in Breast Cancer Survivors
A Phase 1 study testing Single Photon Emission Computed Tomography, Acupuncture Therapy and Questionnaire Administration in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Single Photon Emission Computed Tomography, Acupuncture Therapy and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors
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.
Read the detailed description
Detailed Description
OBJECTIVES:
- 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.
- Conditions
- Breast Cancer
- Being tested
- Single Photon Emission Computed Tomography, Acupuncture Therapy, Questionnaire Administration, Laboratory Biomarker Analysis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Photon Emission Computed TomographyProcedure or surgery
Also called SPECT imaging, tomography, emission computed, single photon
Undergo single photon emission computed tomographt imaging
Acupuncture TherapyProcedure or surgery
Also called Acupuncture
Undergo acupuncture
Questionnaire AdministrationOther
Ancillary study
Laboratory Biomarker AnalysisOther
Correlative Study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Single Photon Emission Computed Tomography; Procedure: Acupuncture Therapy; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Hot flash frequency and severity
Acupuncture expectancy scale
Credibility rating of acupuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Mao, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018108
- Sponsor's protocol ID
- UPCC 17108
- Status last verified
- Jan 2016
- First submitted
- 19 Nov 2009
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Brain Serotonin Among Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01018108
- Acronym / sponsor ID
- UPCC 17108
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Other | Procedure: Single Photon Emission Computed Tomography, Procedure: Acupuncture Therapy, Other: Questionnaire Administration, Other: Laboratory Biomarker AnalysisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Photon Emission Computed TomographyAlso: SPECT imaging, tomography, emission computed, single photonUndergo single photon emission computed tomographt imaging | Procedure or surgery | I |
| Acupuncture TherapyAlso: AcupunctureUndergo acupuncture | Procedure or surgery | I |
| Questionnaire AdministrationAncillary study | Other | I |
| Laboratory Biomarker AnalysisCorrelative Study | Other | I |
Primary outcome
SERT uptake ratios
Hot flash composite score (HFCS)
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Mao, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single Photon Emission Computed Tomography, Acupuncture Therapy and Questionnaire Administration in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SERT uptake ratios. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.