Breast CancerNCT00419822
Acupuncture in the Management of Post Operative Symptoms in Breast Cancer Patients
A study testing Acupuncture in people with Breast Cancer, run by Legacy Health System at 1 site in United States.
Trial summary
This study is for the woman who will have axillary (armpit) surgery as part of their breast cancer treatment. The purpose of this project is to evaluate if acupuncture is helpful to control pain and improve range of motion (arm movement). Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Mar 2011
- Phase
- Interventional
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects
- Expected survival at least 6 months or greater
- Has had surgery with axillary dissection
- Greater than 6 nodes removed during surgery
- Greater than 21 years of age
Who cannot join
- Previous mastectomy
- Double mastectomy at the time of current axillary surgery
- Any diagnoses of autoimmune disease
- Pregnant or lactating women
- Unable to provide written informed consent
- Suspected or diagnosed fibromyalgia
Show all 10Show fewer
- Previous shoulder injuries for the specific arm that will undergo axillary dissection
- Known or suspected drug or alcohol abuse as determined by the investigator
- Decreased range of motion (ROM) as evidenced on standard preoperative exam
- Previous acupuncture (lifetime)
Trial locations and contacts
1 site in 1 country.
United States1 site
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210
About this study
Official title: A Randomized, Intent to Treat, Controlled Study of the Efficacy of Verum Acupuncture Compared to Sham Acupuncture in the Management of Post Operative Symptoms in Breast Cancer Subjects That Have Undergone Axillary Surgery
This study is for the woman who will have axillary (armpit) surgery as part of their breast cancer treatment. The purpose of this project is to evaluate if acupuncture is helpful to control pain and improve range of motion (arm movement). Another goal is to find out if women have an improvement in their quality of life. This study is being done in collaboration with the Oregon College of Oriental Medicine (OCOM).
- Conditions
- Breast Cancer
- Being tested
- Acupuncture, Sham Acupuncture, Patient to receive standard care without Acupuncture or Sham Acupuncture.
- Keywords
- Acupuncture, Range of Motion, Quality of Life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
6 Acupuncture visits
Sham AcupunctureProcedure or surgery
6 Acupuncture visits with sham procedure
Patient to receive standard care without Acupuncture or Sham Acupuncture.Other
Standard care
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Active comparator | Not described Receives: Procedure: Acupuncture |
| Sham Acupuncture | Sham comparator | Not described Receives: Procedure: Sham Acupuncture |
| Standard of Care | Placebo comparator | Not described Receives: Other: Patient to receive standard care without Acupuncture or Sham Acupuncture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the difference in pain and range of motion
Measured: 3 months after surgery
Determine the difference in function
Measured: 3 months after surgery
Determine the difference in quality of life
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study startSep 2006
- Primary completionMar 2011
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Investigators
- Nathalie Johnson, MD, Principal investigator, Legacy Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419822
- Sponsor's protocol ID
- BCA-TCM-001
- Status last verified
- May 2010
- First submitted
- 8 Jan 2007
- Last updated
- 4 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Intent to Treat, Controlled Study of the Efficacy of Verum Acupuncture Compared to Sham Acupuncture in the Management of Post Operative Symptoms in Breast Cancer Subjects That Have Undergone Axillary Surgery
- ClinicalTrials.gov ID
- NCT00419822
- Acronym / sponsor ID
- BCA-TCM-001
- Conditions
- Breast Cancer
- Keywords
- Acupuncture, Range of Motion, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Mar 2011 (actual)
- First posted
- 9 Jan 2007 (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.
This study is for the woman who will have axillary (armpit) surgery as part of their breast cancer treatment. The purpose of this project is to evaluate if acupuncture is helpful to control pain and improve range of motion (arm movement). Another goal is to find out if women have an improvement in their quality of life. This study is being done in collaboration with the Oregon College of Oriental Medicine (OCOM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Active comparator | Procedure: Acupuncture |
| Sham Acupuncture | Sham comparator | Procedure: Sham Acupuncture |
| Standard of Care | Placebo comparator | Other: Patient to receive standard care without Acupuncture or Sham Acupuncture. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female subjects
- Expected survival at least 6 months or greater
- Has had surgery with axillary dissection
- Greater than 6 nodes removed during surgery
- Greater than 21 years of age
Key exclusion criteria (10 listed)
- Previous mastectomy
- Double mastectomy at the time of current axillary surgery
- Any diagnoses of autoimmune disease
- Pregnant or lactating women
- Unable to provide written informed consent
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 |
|---|---|---|
| Acupuncture6 Acupuncture visits | Procedure or surgery | Acupuncture |
| Sham Acupuncture6 Acupuncture visits with sham procedure | Procedure or surgery | Sham Acupuncture |
| Patient to receive standard care without Acupuncture or Sham Acupuncture.Standard care | Other | Standard of Care |
Primary outcome
Determine the difference in pain and range of motion
Time frame: 3 months after surgery
Determine the difference in function
Time frame: 3 months after surgery
Determine the difference in quality of life
Time frame: 3 months after surgery
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 4 Jul 2011.
- Related InfoLink provided by the sponsor.
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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.
Nathalie Johnson, MD principal investigator
Legacy Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Breast Cancer, run by Legacy Health System 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 10 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 4 Jul 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Determine the difference in pain and range of motion (time frame: 3 months after surgery). The study lists 3 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 4 Jul 2011.