Breast CancerNCT01013337
Acupuncture in Treating Women With Stage I, Stage II, or Stage III Breast Cancer With Aromatase Inhibitor-Related Joint Pain
A study testing acupuncture therapy in people with Breast Cancer and Recurrent Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
RATIONALE: Acupuncture may help relieve moderate or severe joint pain caused by aromatase inhibitors. PURPOSE: This randomized phase II trial is studying acupuncture in treating women with stage I, stage II, or stage III breast cancer with aromatase inhibitor-related joint pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Recurrent Breast Cancer, Stage I Breast Cancer
- What is being tested?
- acupuncture therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to 21 Apr 2016
- 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 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
- Visit with oncologist within the previous 3-month period and free of disease by clinical examination and history
- Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) as per chart abstraction
- Postmenopausal, as defined by cessation of menses for a least 1 year or FSH > 40 mlU/mL
- Can understand written English
- Having worst joint pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale in the preceding week
Show all 10Show fewer
- Having had at least 15 days with pain in the preceding 30 days
- Having had joint pain for at least 3 months
- Joint pain attributed to the use of aromatase inhibitors
- Willingness to adhere to all study-related procedures including randomization to one of the three possible choices: real acupuncture, placebo acupuncture, and wait-list control
Who cannot join
- Women with metastatic (stage IV) breast cancer
- Women having finished chemotherapy or radiation therapy less than 4 weeks prior to enrollment
- History of bleeding disorder
- Joint pain attributed to inflammatory arthritis (such as rheumatoid arthritis, gout, pseudo gout)
- Having severe pain or non-inflammatory arthralgia prior to AI initiation per patient's history
- Surgery or joint injection involving the treatment joint within the last 3 months
- Have previously participated in the acupuncture trial for hot flashes in the last year
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: Acupuncture and Aromatase Inhibitor Related Arthralgia
RATIONALE: Acupuncture may help relieve moderate or severe joint pain caused by aromatase inhibitors.
PURPOSE: This randomized phase II trial is studying acupuncture in treating women with stage I, stage II, or stage III breast cancer with aromatase inhibitor-related joint pain.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the overall effect of acupuncture for reducing arthralgia among breast cancer survivors (BCS) receiving AIs.
II. To explore the specific effect of acupuncture needling for reducing arthralgia among BCS receiving AIs.
III. To elucidate the relationship between response expectancy measured by the Acupuncture Expectancy Scale (AES) and clinical response to acupuncture defined as percent reduction of BPI pain severity score at the end of intervention.
SECONDARY OBJECTIVES:
- To explore the effects of acupuncture on other common symptoms including fatigue, insomnia, and psychological distress among BCS who experience joint pain.
II. To determine the correlation among pain and fatigue, insomnia, and psychological distress using previously validated instruments.
III. To explore the effects of acupuncture on quality of life among BCS who experience joint pain.
IV. To explore the effect of acupuncture on objective measure of sleep and activity.
- To identify potential genetic determinants to response to acupuncture.
OUTLINE:
Patients are randomized to 1 of 3 treatment arms.
ARM I (Acupuncture): Patients undergo 10, 20-minute sessions of acupuncture over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments).
ARM II (Placebo): Patients undergo 10, 20-minute sessions of sham acupuncture treatments over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments) via Streitberger needles at non-acupuncture points.
ARM III (Control): Wait-list control patients are contacted by phone at the same frequency as real and placebo acupuncture groups for data collection at weeks 1, 4, and 8.
After completion of study treatment, patients are followed at 4 weeks.
- Conditions
- Breast Cancer, Recurrent Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer
- Being tested
- acupuncture therapy, sham intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture therapyProcedure or surgery
Also called acupuncture
sham interventionProcedure or surgery
Placebo acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Acupuncture) | Experimental | Patients undergo 10, 20-minute sessions of acupuncture over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments). Receives: Procedure: acupuncture therapy |
| Arm II (Placebo) | Sham comparator | Patients undergo 10, 20-minute sessions of sham acupuncture treatments over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments) via Streitberger needles at non-acupuncture points. Receives: Procedure: sham intervention |
| Arm III (Control) | No intervention | Wait-list control patients are contacted by phone at the same frequency as real and placebo acupuncture groups for data collection at weeks 1, 4, and 8. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as measured by Brief Pain Inventory (BPI) pain severity score
Secondary outcomes (4)
BPI pain-related interference
Arthritis/disability specific outcomes as assessed by WOMAC index for lower extremities, quick D.A.S.H. for upper extremities, and the Physical Performance Test, 9-item
Patient perceived clinical importance of acupuncture for AI-related arthralgia as assessed by Patient Global Impression of Change (PGIC)
Other coexisting symptoms such as fatigue, psychological distress, and insomnia as assessed by the Brief Fatigue Inventory (BFI), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index, and City of Hope Quality of Life Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2012
- Study completion21 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Mao, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013337
- Sponsor's protocol ID
- UPCC 07109
- Other IDs
- NCI-2009-01358
- Status last verified
- Apr 2020
- First submitted
- 12 Nov 2009
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bao T, Li SQ, Dearing JL, Piulson LA, Seluzicki CM, Sidlow R, Mao JJ. Acupuncture versus medication for pain management: a cross-sectional study of breast cancer survivors. Acupunct Med. 2018 Apr;36(2):80-87. doi: 10.1136/acupmed-2017-011435. Epub 2018 Feb 10.
PubMed 29440043Mao JJ, Xie SX, Farrar JT, Stricker CT, Bowman MA, Bruner D, DeMichele A. A randomised trial of electro-acupuncture for arthralgia related to aromatase inhibitor use. Eur J Cancer. 2014 Jan;50(2):267-76. doi: 10.1016/j.ejca.2013.09.022. Epub 2013 Oct 24.
PubMed 24210070
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Aromatase Inhibitor Related Arthralgia
- ClinicalTrials.gov ID
- NCT01013337
- Acronym / sponsor ID
- UPCC 07109
- Conditions
- Breast Cancer, Recurrent Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- 21 Apr 2016 (actual)
- First posted
- 13 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: Acupuncture may help relieve moderate or severe joint pain caused by aromatase inhibitors.
PURPOSE: This randomized phase II trial is studying acupuncture in treating women with stage I, stage II, or stage III breast cancer with aromatase inhibitor-related joint pain.
Detailed description
PRIMARY OBJECTIVES:
- To determine the overall effect of acupuncture for reducing arthralgia among breast cancer survivors (BCS) receiving AIs.
II. To explore the specific effect of acupuncture needling for reducing arthralgia among BCS receiving AIs.
III. To elucidate the relationship between response expectancy measured by the Acupuncture Expectancy Scale (AES) and clinical response to acupuncture defined as percent reduction of BPI pain severity score at the end of intervention.
SECONDARY OBJECTIVES:
- To explore the effects of acupuncture on other common symptoms including fatigue, insomnia, and psychological distress among BCS who experience joint pain.
II. To determine the correlation among pain and fatigue, insomnia, and psychological distress using previously validated instruments.
III. To explore the effects of acupuncture on quality of life among BCS who experience joint pain.
IV. To explore the effect of acupuncture on objective measure of sleep and activity.
- To identify potential genetic determinants to response to acupuncture.
OUTLINE:
Patients are randomized to 1 of 3 treatment arms.
ARM I (Acupuncture): Patients undergo 10, 20-minute sessions of acupuncture over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments).
ARM II (Placebo): Patients undergo 10, 20-minute sessions of sham acupuncture treatments over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments) via Streitberger needles at non-acupuncture points.
ARM III (Control): Wait-list control patients are contacted by phone at the same frequency as real and placebo acupuncture groups for data collection at weeks 1, 4, and 8.
After completion of study treatment, patients are followed at 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (Acupuncture) | Experimental | Procedure: acupuncture therapyPatients undergo 10, 20-minute sessions of acupuncture over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments). |
| Arm II (Placebo) | Sham comparator | Procedure: sham interventionPatients undergo 10, 20-minute sessions of sham acupuncture treatments over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments) via Streitberger needles at non-acupuncture points. |
| Arm III (Control) | No intervention | –Wait-list control patients are contacted by phone at the same frequency as real and placebo acupuncture groups for data collection at weeks 1, 4, and 8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- History of stage I, II, or III breast cancer
- Visit with oncologist within the previous 3-month period and free of disease by clinical examination and history
- Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) as per chart abstraction
- Postmenopausal, as defined by cessation of menses for a least 1 year or FSH > 40 mlU/mL
- Can understand written English
Key exclusion criteria (7 listed)
- Women with metastatic (stage IV) breast cancer
- Women having finished chemotherapy or radiation therapy less than 4 weeks prior to enrollment
- History of bleeding disorder
- Joint pain attributed to inflammatory arthritis (such as rheumatoid arthritis, gout, pseudo gout)
- Having severe pain or non-inflammatory arthralgia prior to AI initiation per patient's history
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 therapyAlso: acupuncture | Procedure or surgery | Arm I (Acupuncture) |
| sham interventionPlacebo acupuncture | Procedure or surgery | Arm II (Placebo) |
Primary outcome
Pain as measured by Brief Pain Inventory (BPI) pain severity score
4 secondary outcomes
BPI pain-related interference
Arthritis/disability specific outcomes as assessed by WOMAC index for lower extremities, quick D.A.S.H. for upper extremities, and the Physical Performance Test, 9-item
Patient perceived clinical importance of acupuncture for AI-related arthralgia as assessed by Patient Global Impression of Change (PGIC)
Other coexisting symptoms such as fatigue, psychological distress, and insomnia as assessed by the Brief Fatigue Inventory (BFI), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index, and City of Hope Quality of Life Questionnaire
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 8 Apr 2020.
- Derived from this study: PubMed 29440043Bao T, Li SQ, Dearing JL, Piulson LA, Seluzicki CM, Sidlow R, Mao JJ. Acupuncture versus medication for pain management: a cross-sectional study of breast cancer survivors. Acupunct Med. 2018 Apr;36(2):80-87. doi: 10.1136/acupmed-2017-011435. Epub 2018 Feb 10.
- Derived from this study: PubMed 24210070Mao JJ, Xie SX, Farrar JT, Stricker CT, Bowman MA, Bruner D, DeMichele A. A randomised trial of electro-acupuncture for arthralgia related to aromatase inhibitor use. Eur J Cancer. 2014 Jan;50(2):267-76. doi: 10.1016/j.ejca.2013.09.022. Epub 2013 Oct 24.
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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 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 study testing acupuncture therapy in people with Breast Cancer and Recurrent 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 10 inclusion and 7 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 8 Apr 2020. 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?
Pain as measured by Brief Pain Inventory (BPI) pain severity score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01013337, which also lists 2 linked publications.
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 8 Apr 2020.