Breast CancerPhase 2AIANCT01612728
Treatment for Joint Pains Due to Aromatase Inhibitor Therapy in Breast Cancer
A Phase 2 study testing Women without Arthralgia and Women with Arthralgia in people with Breast Cancer and Arthralgia, run by Baylor Breast Care Center.
Trial summary
Aromatase inhibitors are the most effective adjuvant anti-hormonal therapy for estrogen receptor positive (ER+) post-menopausal breast cancer patients, with proven superiority over tamoxifen in terms of disease-free survival, time to recurrence, and contralateral breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Arthralgia, Joint Pain
- What is being tested?
- Women without Arthralgia and Women with Arthralgia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Oct 2014
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age greater than 18 years
- stage I-III ER+ breast cancer
- beginning adjuvant AI therapy
- post-menopausal as defined by any of the following: age >60 years, history of bilateral oophorectomy, amenorrhea for 1 year with intact uterus and ovaries, or serum estradiol and FSH concentrations in the post-menopausal range along with either amenorrhea for 6 months or previous hysterectomy
Who cannot join
- previous use of an aromatase inhibitor
About this study
Official title: Aromatase Inhibitor-Induced Arthralgia: A Proposed Management Algorithm
Aromatase inhibitors are the most effective adjuvant anti-hormonal therapy for estrogen receptor positive (ER+) post-menopausal breast cancer patients, with proven superiority over tamoxifen in terms of disease-free survival, time to recurrence, and contralateral breast cancer. However, approximately half of the women who take this drug will develop significant joint pains, termed Aromatase Inhibitor-Induced Arthralgia (AIA). Though this medicine should be taken for 5 years, the joint pain can be so troublesome that up to 13% may prematurely discontinue it because of the arthralgia, thus sacrificing their best chance of recurrence-free survival. Nonetheless, neither the etiology nor optimal management of AIA is clearly understood, leaving both doctor and patient rather frustrated.
The investigators therefore propose to test the hypothesis that AIA can be effectively treated by a new clinical algorithm, and that effective treatment of the problem will lead to improved compliance with Aromatase Inhibitor (AI) therapy. The algorithm is a clinical pathway for treating AIA which incorporates, in a rational and step-wise manner, a series of interventions based on the available evidence. Interventions include acupuncture, pain medication, weight bearing exercise, and other commonly used therapies for AIA.
Read more
The investigators will enroll 100 women who are beginning adjuvant AI therapy and assess each woman's baseline joint pains via a questionnaire as well as grip strength measurement. The investigators will then periodically repeat these tests during AI therapy in order to systematically quantify and characterize AIA. Those women who develop AIA during the course of the study will be placed on the clinical algorithm, and the investigators will observe whether their joint pains significantly improve (as measured by questionnaire and grip strength measurement) after institution of the algorithm. The investigators will also determine whether their compliance is improved compared to historical controls, and at least non-inferior to the women in the study who do not develop AIA. Finally, the investigators will measure serum estrogen level at baseline and then periodically during AI therapy to investigate whether more dramatic decline in estrogen level after initiation of an AI leads to significant AIA and earlier time to onset.
This study targets a very common cause of pain among breast cancer survivors and aims to offer an effective treatment strategy to alleviate pain and improve quality of life as well as medication compliance.
- Conditions
- Breast Cancer, Arthralgia, Joint Pain
- Being tested
- Women without Arthralgia, Women with Arthralgia
- Keywords
- Aromatase Inhibitors
- Medical subject headings
- Breast Neoplasms, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women without ArthralgiaOther
For mild arthralgia, women will try the following interventions in the following order: 1) Weight-bearing exercise program, and 2) Glucosamine \& Chondroitin supplements. For women with mild to moderate arthralgia, they will try to the following interventions in this order: 1) Acupuncture, 2) Indomethacin twice daily as needed, 3) Switch to a different aromatase inhibitor, and 4) Switch to tamoxifen.
Women with ArthralgiaDrug
Also called Aromatase Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Women with Arthralgia | Experimental | Women who develop joint pain on Aromatase Inhibitor therapy will be placed on the clinical algorithm, as specified in the protocol. Receives: Drug: Women with Arthralgia |
| Women without Arthralgia | Other | Women who do not develop arthralgia will continue to have their joint pain and strength measured, as well as their medication compliance. However, they will not be placed on the clinical algorithm which is meant for alleviation of joint pains. Receives: Other: Women without Arthralgia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication compliance
The primary objective of the study will be to estimate medication compliance among women with and without arthralgia with use of the proposed algorithm in those women with AIA.
Measured: 9 months
Secondary outcomes (1)
improvement of AIA symptoms with use of the algorithm
The secondary objectives of the study will be correlation of the estrogen level with clinical development of arthralgia, as well as greater improvement of AIA symptoms with use of the algorithm.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startOct 2013
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Why it stopped: The grant application for this project was rejected.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Breast Care Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Polly Niravath, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612728
- Sponsor's protocol ID
- AIA-001
- Acronym
- AIA
- Status last verified
- Feb 2013
- First submitted
- 4 Jun 2012
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatase Inhibitor-Induced Arthralgia: A Proposed Management Algorithm
- ClinicalTrials.gov ID
- NCT01612728
- Acronym / sponsor ID
- AIA / AIA-001
- Conditions
- Breast Cancer, Arthralgia, Joint Pain
- Keywords
- Aromatase Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The grant application for this project was rejected.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor Breast Care CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 6 Jun 2012 (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.
Aromatase inhibitors are the most effective adjuvant anti-hormonal therapy for estrogen receptor positive (ER+) post-menopausal breast cancer patients, with proven superiority over tamoxifen in terms of disease-free survival, time to recurrence, and contralateral breast cancer. However, approximately half of the women who take this drug will develop significant joint pains, termed Aromatase Inhibitor-Induced Arthralgia (AIA). Though this medicine should be taken for 5 years, the joint pain can be so troublesome that up to 13% may prematurely discontinue it because of the arthralgia, thus sacrificing their best chance of recurrence-free survival. Nonetheless, neither the etiology nor optimal management of AIA is clearly understood, leaving both doctor and patient rather frustrated.
The investigators therefore propose to test the hypothesis that AIA can be effectively treated by a new clinical algorithm, and that effective treatment of the problem will lead to improved compliance with Aromatase Inhibitor (AI) therapy. The algorithm is a clinical pathway for treating AIA which incorporates, in a rational and step-wise manner, a series of interventions based on the available evidence. Interventions include acupuncture, pain medication, weight bearing exercise, and other commonly used therapies for AIA.
The investigators will enroll 100 women who are beginning adjuvant AI therapy and assess each woman's baseline joint pains via a questionnaire as well as grip strength measurement. The investigators will then periodically repeat these tests during AI therapy in order to systematically quantify and characterize AIA. Those women who develop AIA during the course of the study will be placed on the clinical algorithm, and the investigators will observe whether their joint pains significantly improve (as measured by questionnaire and grip strength measurement) after institution of the algorithm. The investigators will also determine whether their compliance is improved compared to historical controls, and at least non-inferior to the women in the study who do not develop AIA. Finally, the investigators will measure serum estrogen level at baseline and then periodically during AI therapy to investigate whether more dramatic decline in estrogen level after initiation of an AI leads to significant AIA and earlier time to onset.
This study targets a very common cause of pain among breast cancer survivors and aims to offer an effective treatment strategy to alleviate pain and improve quality of life as well as medication compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with Arthralgia | Experimental | Drug: Women with ArthralgiaWomen who develop joint pain on Aromatase Inhibitor therapy will be placed on the clinical algorithm, as specified in the protocol. |
| Women without Arthralgia | Other | Other: Women without ArthralgiaWomen who do not develop arthralgia will continue to have their joint pain and strength measured, as well as their medication compliance. However, they will not be placed on the clinical algorithm which is meant for alleviation of joint pains. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age greater than 18 years
- stage I-III ER+ breast cancer
- beginning adjuvant AI therapy
- post-menopausal as defined by any of the following: age >60 years, history of bilateral oophorectomy, amenorrhea for 1 year with intact uterus and ovaries, or serum estradiol and FSH concentrations in the post-menopausal range along with either amenorrhea for 6 months or previous hysterectomy
Key exclusion criteria (1 listed)
- previous use of an aromatase inhibitor
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 |
|---|---|---|
| Women without ArthralgiaFor mild arthralgia, women will try the following interventions in the following order: 1) Weight-bearing exercise program, and 2) Glucosamine \& Chondroitin supplements. For women with mild to moderate arthralgia, they will try to the following interventions in this order: 1) Acupuncture, 2) Indomethacin twice daily as needed, 3) Switch to a different aromatase inhibitor, and 4) Switch to tamoxifen. | Other | Women without Arthralgia |
| Women with ArthralgiaAlso: Aromatase Inhibitor | Drug | Women with Arthralgia |
Primary outcome
Medication compliance
Time frame: 9 months
The primary objective of the study will be to estimate medication compliance among women with and without arthralgia with use of the proposed algorithm in those women with AIA.
1 secondary outcome
improvement of AIA symptoms with use of the algorithm
Time frame: 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
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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.
Polly Niravath, MD principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Women without Arthralgia and Women with Arthralgia in people with Breast Cancer and Arthralgia, run by Baylor Breast Care Center.
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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 12 Feb 2013. 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 withdrawn before enrolling participants, so there are no results.
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?
Medication compliance (time frame: 9 months). 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 12 Feb 2013.