Breast CancerNCT01236417
Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia
A study testing Exercising block in people with Breast Cancer and Arthralgia, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This is a pilot study of a specifically designed exercise intervention developed for breast cancer patients 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, Arthralgia
- What is being tested?
- Exercising block
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Mar 2012
- 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
- Post menopausal women with a history of estrogen positive breast cancer who are receiving aromatase inhibitors for at least one month.
- Patients must complain of mild to moderate arthralgia.
- Ability to understand and sign informed consent.
- Patients meet criteria for low to moderate risk for moderate exercise based oon the ACSM guidelines.
Who cannot join
- Inability to comply with study requirements.
- Metastatic breast cancer.
- Patients with orthopedic or neuromuscular disorders that preclude participation in exercise.
- Rheumatoid arthritis.
- History of MI, angina or congestive heart failure.
- Pregnant or lactating females.
Show all 9Show fewer
- Patients that are high risk for moderate exercise based on ACSM risk classification.
- Patients who exceed minimal physical activity recommendations from the US Surgeon General's Report: Accumulation of 30 minutes or more of moderate physical activity on most days of the week.
- Morbidly obese with BMI ≥ 40
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
This is a pilot study of a specifically designed exercise intervention developed for breast cancer patients with aromatase-inhibitor related joint pain.
- Conditions
- Breast Cancer, Arthralgia
- Being tested
- Exercising block
- 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.
Exercising blockBehavioural
Exercising for 8 weeks using an elastic band
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Subjects will be participating in a home-based flexibility and exercise program Receives: Behavioral: Exercising block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of exercise
To assess the effect of an exercise intervention in breast cancer patients with arthralgia secondary to adjuvant treatment with aromatase inhibitors.
Measured: Length of study
Secondary outcomes (1)
Feasibility of Multi-institutional study
To perform a pilot to access the feasibility of a multi-institutional approach
Measured: Length of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2012
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 Roswell Park Cancer InstituteThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracy O'Connor, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236417
- Sponsor's protocol ID
- I 169310
- Status last verified
- Apr 2012
- First submitted
- 5 Nov 2010
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia
- ClinicalTrials.gov ID
- NCT01236417
- Acronym / sponsor ID
- I 169310
- Conditions
- Breast Cancer, Arthralgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (actual)
- First posted
- 8 Nov 2010 (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 is a pilot study of a specifically designed exercise intervention developed for breast cancer patients with aromatase-inhibitor related joint pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercising blockSubjects will be participating in a home-based flexibility and exercise program |
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)
- Post menopausal women with a history of estrogen positive breast cancer who are receiving aromatase inhibitors for at least one month.
- Patients must complain of mild to moderate arthralgia.
- Ability to understand and sign informed consent.
- Patients meet criteria for low to moderate risk for moderate exercise based oon the ACSM guidelines.
Key exclusion criteria (9 listed)
- Inability to comply with study requirements.
- Metastatic breast cancer.
- Patients with orthopedic or neuromuscular disorders that preclude participation in exercise.
- Rheumatoid arthritis.
- History of MI, angina or congestive heart failure.
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 |
|---|---|---|
| Exercising blockExercising for 8 weeks using an elastic band | Behavioural | Exercise |
Primary outcome
Effects of exercise
Time frame: Length of study
To assess the effect of an exercise intervention in breast cancer patients with arthralgia secondary to adjuvant treatment with aromatase inhibitors.
1 secondary outcome
Feasibility of Multi-institutional study
Time frame: Length of the study
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 13 Apr 2012.
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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.
Tracy O'Connor, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercising block in people with Breast Cancer and Arthralgia, run by Roswell Park Cancer Institute 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 4 inclusion and 9 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 13 Apr 2012. 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?
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?
Effects of exercise (time frame: Length of study). 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 13 Apr 2012.