Breast CancerLOGRIBMETNCT01896050
Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer
An observational study of Breast Cancer and Arthralgia, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Arthralgia, Obesity
- What is being tested?
- anastrozole, letrozole, exemestane and Tamoxifen
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Postmenopausal women with hormone receptor positive breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen.
Who may be able to join
- Stage 0-III breast cancer who are scheduled to receive endocrine therapy with tamoxifen or an aromatase inhibitor
- All prior surgery and chemotherapy should be complete
- Age 18 and above and postmenopausal
Who cannot join
- Major rheumatologic disorders
- Concomitant sex hormone containing drugs or Leutinizing Hormone Releasing Hormone agonist therapy
- For those subjects initiating treatment with an aromatase inhibitor, prior tamoxifen within 4 weeks of enrollment
- For those subjects initiating treatment with tamoxifen, prior aromatase inhibitor within 4 weeks of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Third-generation Aromatase Inhibitors and Tamoxifen
Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. Initial reports suggest that grip strength decreases during aromatase inhibitor therapy, and that body-mass index may influence development of this symptom. Therefore, this longitudinal study has been developed to determine change in grip strength over time in women treated with aromatase inhibitors and tamoxifen, as well as to identify potential associations between change in grip strength and BMI. Patient self-reported symptoms will also be collected. A total of 115 women with early stage breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen will be enrolled.
- Conditions
- Breast Cancer, Arthralgia, Obesity
- Being tested
- anastrozole, letrozole, exemestane, Tamoxifen
- Keywords
- Joint pain, Grip strength, Hormone receptor positive breast cancer
- Medical subject headings
- Breast Neoplasms, Arthralgia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anastrozole, letrozole, exemestaneDrug
Also called Arimidex, Femara, Aromasin
Patients were treated with one of the listed anti-hormonal medications for up to one year
TamoxifenDrug
Also called Novaldex
Patients were treated with tamoxifen for up to one year
| Study group | Role | What they receive |
|---|---|---|
| AI therapy | Subjects who started treatment with any of the three aromatase inhibitor (AI) medications Receives: Drug: anastrozole, letrozole, exemestane | |
| Tamoxifen | Subjects who started treatment with tamoxifen Receives: Drug: Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy
Change in BMI between baseline and 12 months of endocrine therapy
Measured: baseline and 12 months
Secondary outcomes (2)
Effect of Medication on Change in Grip Strength
Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months
Measured: baseline and 12 months
Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months
Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startSep 2009
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynn Henry, University of Michigan Rogel Cancer Center
- Investigators
- Norah L Henry, MD, PhD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896050
- Sponsor's protocol ID
- UMCC 2009.029
- Acronym
- LOGRIBMET
- Status last verified
- May 2016
- First submitted
- 5 Jul 2013
- Last updated
- 28 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Third-generation Aromatase Inhibitors and Tamoxifen
- ClinicalTrials.gov ID
- NCT01896050
- Acronym / sponsor ID
- LOGRIBMET / UMCC 2009.029
- Conditions
- Breast Cancer, Arthralgia, Obesity
- Keywords
- Joint pain, Grip strength, Hormone receptor positive breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Posted 12 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. Initial reports suggest that grip strength decreases during aromatase inhibitor therapy, and that body-mass index may influence development of this symptom. Therefore, this longitudinal study has been developed to determine change in grip strength over time in women treated with aromatase inhibitors and tamoxifen, as well as to identify potential associations between change in grip strength and BMI. Patient self-reported symptoms will also be collected. A total of 115 women with early stage breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI therapy | – | Drug: anastrozole, letrozole, exemestaneSubjects who started treatment with any of the three aromatase inhibitor (AI) medications |
| Tamoxifen | – | Drug: TamoxifenSubjects who started treatment with tamoxifen |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women with hormone receptor positive breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen.
Key inclusion criteria (3 listed)
- Stage 0-III breast cancer who are scheduled to receive endocrine therapy with tamoxifen or an aromatase inhibitor
- All prior surgery and chemotherapy should be complete
- Age 18 and above and postmenopausal
Key exclusion criteria (4 listed)
- Major rheumatologic disorders
- Concomitant sex hormone containing drugs or Leutinizing Hormone Releasing Hormone agonist therapy
- For those subjects initiating treatment with an aromatase inhibitor, prior tamoxifen within 4 weeks of enrollment
- For those subjects initiating treatment with tamoxifen, prior aromatase inhibitor within 4 weeks of enrollment
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 |
|---|---|---|
| anastrozole, letrozole, exemestaneAlso: Arimidex, Femara, AromasinPatients were treated with one of the listed anti-hormonal medications for up to one year | Drug | AI therapy |
| TamoxifenAlso: NovaldexPatients were treated with tamoxifen for up to one year | Drug | Tamoxifen |
Primary outcome
Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy
Time frame: baseline and 12 months
Change in BMI between baseline and 12 months of endocrine therapy
2 secondary outcomes
Effect of Medication on Change in Grip Strength
Time frame: baseline and 12 months
Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months
Time frame: baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Norah L Henry, MD, PhD principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Arthralgia, run by University of Michigan Rogel Cancer Center 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 3 inclusion and 4 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 28 Jun 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy (time frame: baseline and 12 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 28 Jun 2016.