Breast CancerPhase 2NCT00892268
Acupuncture or Medication in Reducing Pain in Postmenopausal Women With Breast Cancer and Joint Pain
A Phase 2 study testing acupuncture therapy and pain therapy in people with Breast Cancer and Menopausal Symptoms, run by University of Arizona.
Trial summary
RATIONALE: Acupuncture may reduce joint pain in postmenopausal women with breast cancer. It is not yet known whether acupuncture is more effective than standard therapy analgesics in decreasing joint pain caused by aromatase inhibitors. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Menopausal Symptoms, Pain
- What is being tested?
- acupuncture therapy and pain therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Oct 2009
- Phase
- Phase 2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Concurrent therapy with anastrozole for the adjuvant treatment of breast cancer
- Must have moderate or worse arthralgia, as defined by a baseline WOMAC pain scale score ≥ 48
- Patients with other underlying pain syndromes (e.g., osteoarthritis) are eligible, but the arthralgia must have worsened since starting anastrozole
- Hormone receptor-positive disease
PATIENT CHARACTERISTICS:
- Post-menopausal status meeting the following criteria:
- At least 12 months without spontaneous menstrual bleeding
- History of bilateral salpingo-oophorectomy with or without hysterectomy
- Age > 55 with hysterectomy with or without oophorectomy
- Age < 55 with hysterectomy without oophorectomy or with unknown status, and serum FSH in post-menopausal range within the past 4 weeks
- Not needle phobic
- Patients with a contraindication to NSAIDs (i.e., prior gastrointestinal bleed secondary to NSAIDs or severe renal insufficiency) are eligible, but will be treated with alternative analgesics such as narcotics or acetaminophen
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent chronic narcotics or NSAIDs allowed, but doses must be stable for ≥ the past month
- Concurrent antidepressant medications allowed, but doses must be stable for ≥ the past 3 months
- At least 6 months since prior acupuncture
- No prior acupuncture for aromatase inhibitor-associated pain syndrome
About this study
Official title: Acupuncture for the Treatment of Aromatase Inhibitor Associated Joint Pain in Post-Menopausal Breast Cancer Patients
RATIONALE: Acupuncture may reduce joint pain in postmenopausal women with breast cancer. It is not yet known whether acupuncture is more effective than standard therapy analgesics in decreasing joint pain caused by aromatase inhibitors.
PURPOSE: This randomized phase II trial is studying acupuncture to see how well it works compared with medication in reducing pain in postmenopausal women with breast cancer and joint pain.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the efficacy of acupuncture in reducing pain, defined by improvements in overall WOMAC score at 6 weeks, in post-menopausal women with breast cancer and aromatase inhibitor (AI)-associated arthralgia.
Secondary
- To identify biologic correlates to acupuncture efficacy in this specific syndrome of AI-associated pain.
- To evaluate the efficacy of acupuncture in these patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms:
- Arm I: Patients undergo acupuncture for 20-30 minutes, on the appropriate pain points on the anterior portion of the body alternating with posterior portion of the body, thrice weekly for 2 weeks and then twice weekly for 3 weeks.
- Arm II: Patients receive standard-of-care analgesics (i.e., NSAIDs, narcotics, acetaminophen, or other) for 5 weeks. Patients not responding to analgesia may cross over to arm I.
Patients are assessed periodically for improvement in pain, menopausal symptoms, and overall quality of life by the WOMAC, Brief Pain Inventory, and FACT-ES questionnaires.
Blood samples are collected at baseline, 6 weeks, 3 months, and 6 months for biomarker studies of brain-derived neurotrophic factor and serotonin-transporter gene polymorphisms levels by ELISA.
After completion of study therapy, patients are followed at 1 week, 6 weeks, 3 months, and 6 months.
- Conditions
- Breast Cancer, Menopausal Symptoms, Pain
- Being tested
- acupuncture therapy, pain therapy
- Keywords
- menopausal symptoms, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, breast cancer, pain
- Medical subject headings
- Breast Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture therapyProcedure or surgery
Undergo acupuncture
pain therapyProcedure or surgery
Receive standard care
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo acupuncture for 20-30 minutes, on the appropriate pain points on the anterior portion of the body alternating with posterior portion of the body, thrice weekly for 2 weeks and then twice weekly for 3 weeks. Receives: Procedure: acupuncture therapy |
| Arm II | Active comparator | Patients receive standard-of-care analgesics (i.e., NSAIDs, narcotics, acetaminophen, or other) for 5 weeks. Patients not responding to analgesia may cross over to arm I. Receives: Procedure: pain therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pain, as defined by the WOMAC global score at 6 weeks
Secondary outcomes (2)
Acupuncture efficacy as defined by bio-correlates, e.g., changes in BDNF and STGP levels
Menopausal symptoms as defined by the FACT-ES
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startJan 2008
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Poor accural
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 University of ArizonaThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Leona B. Downey, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892268
- Sponsor's protocol ID
- CDR0000629150
- Other IDs
- P30CA023074, UARIZ-07-0792-04, IRUSANAS0084
- Status last verified
- May 2009
- First submitted
- 1 May 2009
- Last updated
- 27 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for the Treatment of Aromatase Inhibitor Associated Joint Pain in Post-Menopausal Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00892268
- Acronym / sponsor ID
- CDR0000629150
- Conditions
- Breast Cancer, Menopausal Symptoms, Pain
- Keywords
- menopausal symptoms, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, breast cancer, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accural
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 4 May 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: Acupuncture may reduce joint pain in postmenopausal women with breast cancer. It is not yet known whether acupuncture is more effective than standard therapy analgesics in decreasing joint pain caused by aromatase inhibitors.
PURPOSE: This randomized phase II trial is studying acupuncture to see how well it works compared with medication in reducing pain in postmenopausal women with breast cancer and joint pain.
Detailed description
OBJECTIVES:
Primary
- To evaluate the efficacy of acupuncture in reducing pain, defined by improvements in overall WOMAC score at 6 weeks, in post-menopausal women with breast cancer and aromatase inhibitor (AI)-associated arthralgia.
Secondary
- To identify biologic correlates to acupuncture efficacy in this specific syndrome of AI-associated pain.
- To evaluate the efficacy of acupuncture in these patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms:
- Arm I: Patients undergo acupuncture for 20-30 minutes, on the appropriate pain points on the anterior portion of the body alternating with posterior portion of the body, thrice weekly for 2 weeks and then twice weekly for 3 weeks.
- Arm II: Patients receive standard-of-care analgesics (i.e., NSAIDs, narcotics, acetaminophen, or other) for 5 weeks. Patients not responding to analgesia may cross over to arm I.
Patients are assessed periodically for improvement in pain, menopausal symptoms, and overall quality of life by the WOMAC, Brief Pain Inventory, and FACT-ES questionnaires.
Blood samples are collected at baseline, 6 weeks, 3 months, and 6 months for biomarker studies of brain-derived neurotrophic factor and serotonin-transporter gene polymorphisms levels by ELISA.
After completion of study therapy, patients are followed at 1 week, 6 weeks, 3 months, and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: acupuncture therapyPatients undergo acupuncture for 20-30 minutes, on the appropriate pain points on the anterior portion of the body alternating with posterior portion of the body, thrice weekly for 2 weeks and then twice weekly for 3 weeks. |
| Arm II | Active comparator | Procedure: pain therapyPatients receive standard-of-care analgesics (i.e., NSAIDs, narcotics, acetaminophen, or other) for 5 weeks. Patients not responding to analgesia may cross over to arm I. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| acupuncture therapyUndergo acupuncture | Procedure or surgery | Arm I |
| pain therapyReceive standard care | Procedure or surgery | Arm II |
Primary outcome
Improvement in pain, as defined by the WOMAC global score at 6 weeks
2 secondary outcomes
Acupuncture efficacy as defined by bio-correlates, e.g., changes in BDNF and STGP levels
Menopausal symptoms as defined by the FACT-ES
Results and safety
The study was stopped early (reason given: Poor accural). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2010.
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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.
Leona B. Downey, MD principal investigator
University of Arizona
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acupuncture therapy and pain therapy in people with Breast Cancer and Menopausal Symptoms, run by University of Arizona.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Poor accural). Results are not available in the source record.
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?
Improvement in pain, as defined by the WOMAC global score at 6 weeks. 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 27 Apr 2010.