Musculoskeletal SymptomsPhase 3RAENCT00519883
Randomized Anastrozole Exercise Trial
A Phase 3 study testing Exercise and Supportive Care in people with Musculoskeletal Symptoms, run by British Columbia Cancer Agency at 2 sites in Canada.
Trial summary
This is a randomized, phase III trial of a 12 week exercise program, followed by a 36 week voluntary, self-directed exercise program (total 48 weeks) compared to standard supportive care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Musculoskeletal Symptoms
- What is being tested?
- Exercise and Supportive Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2007to Jul 2010
- Phase
- Phase 3
- 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
- Women who have been on an adjuvant AI for at least 6 weeks.
- The presence of some musculoskeletal symptoms.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1
- ER and or PgR positive early breast cancer, stages I, II or III
- Completion of any adjuvant chemotherapy (if given) and primary breast cancer surgery.
- Be willing to switch to Anastrozole if on another AI
- Signed written informed consent
Who cannot join
- Metastatic disease (no imaging or labs required in absence of clinical suspicion of metastases)
- Evidence or history of inflammatory arthropathy (for example, rheumatoid arthritis)
- Any medical condition (for example, significant heart disease) that would prevent a subject from completing an exercise program.
- Unable to take Aromatase Inhibitor (AI)
- Planned secondary reconstruction procedures during the 48 week study period
- Any medical, physical, geographic, emotional, or economic condition that in the judgement of the clinician/study doctor, would make an individual unable or unlikely to be able to exercise three times a week for 12 weeks.
- Unable to complete a study log book and questionnaires (unable to read and write English and no one at home who can adequately do so).
- The use of any exogeneous estrogen and/or progesterone except Estring and natural plant estrogens
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
BC Cancer Agency Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
BC Cancer Agency Vancouver Island
Victoria, British Columbia, V8R 6V5
About this study
Official title: Randomized Anastrozole Exercise Trial (The RAE Study)
This is a randomized, phase III trial of a 12 week exercise program, followed by a 36 week voluntary, self-directed exercise program (total 48 weeks) compared to standard supportive care. The purpose of the trial is to determine whether the exercise program is better than standard supportive care to decrease the muscle and joint aches (musculoskeletal symptoms) that result from aromatase inhibitors.
Hypothesis An exercise program that includes stretching, strengthening and aerobic components may improve physical quality of life among women with musculoskeletal symptoms who are taking aromatase inhibitors.
- Conditions
- Musculoskeletal Symptoms
- Being tested
- Exercise, Supportive Care
- Keywords
- Anastrozole, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Supportive CareOther
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Arm A: Standard Supportive Care (no supervised exercise) Receives: Other: Supportive Care |
| B | Experimental | Arm B: Exercise Intervention Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the mean SF36 physical component summary (PCS) score for subjects in each study Arm after 12 weeks.
Secondary outcomes (6)
Difference in musculoskeletal symptoms as measured by VAS and NCIC-CTC toxicity criteria.
Global QOL: As measured by SF36 and VAS composite scores at each scheduled follow up visit (Baseline, weeks 4,8,12,24,36,48). See Appendix B for instruments.
Hot Flashes: A hot flash scale will be given to subjects to complete at each scheduled follow up visit (baseline, week 4,8,12,24,36,48). Severity and frequency of hot flashes will be compared between the exercise and control groups at each time point
Arm Circumferences: Arm circumferences will be measured for all subjects on both arms as described in Appendix D at each study follow up visit except weeks 4, 8, and 36.
Bone Mineral Density.
Body Mass Weight, in kilograms, will be recorded for all subjects at baseline and at weeks 4,8,12,24,36, and 48 week visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startDec 2007
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal SymptomsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hagen Kennecke, MD, Principal investigator, BC Cancer Agency Vancouver CentreCaroline Lohrisch, MD, Principal investigator, BC Cancer Agency - Vancouver Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519883
- Sponsor's protocol ID
- RAE Study
- Acronym
- RAE
- Status last verified
- Aug 2014
- First submitted
- 22 Aug 2007
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Anastrozole Exercise Trial (The RAE Study)
- ClinicalTrials.gov ID
- NCT00519883
- Acronym / sponsor ID
- RAE / RAE Study
- Conditions
- Musculoskeletal Symptoms
- Keywords
- Anastrozole, Exercise
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jul 2010 (actual)
- First posted
- 23 Aug 2007 (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 randomized, phase III trial of a 12 week exercise program, followed by a 36 week voluntary, self-directed exercise program (total 48 weeks) compared to standard supportive care. The purpose of the trial is to determine whether the exercise program is better than standard supportive care to decrease the muscle and joint aches (musculoskeletal symptoms) that result from aromatase inhibitors.
Hypothesis An exercise program that includes stretching, strengthening and aerobic components may improve physical quality of life among women with musculoskeletal symptoms who are taking aromatase inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Other: Supportive CareArm A: Standard Supportive Care (no supervised exercise) |
| B | Experimental | Other: ExerciseArm B: Exercise Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women who have been on an adjuvant AI for at least 6 weeks.
- The presence of some musculoskeletal symptoms.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1
- ER and or PgR positive early breast cancer, stages I, II or III
- Completion of any adjuvant chemotherapy (if given) and primary breast cancer surgery.
Key exclusion criteria (8 listed)
- Metastatic disease (no imaging or labs required in absence of clinical suspicion of metastases)
- Evidence or history of inflammatory arthropathy (for example, rheumatoid arthritis)
- Any medical condition (for example, significant heart disease) that would prevent a subject from completing an exercise program.
- Unable to take Aromatase Inhibitor (AI)
- Planned secondary reconstruction procedures during the 48 week study period
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 |
|---|---|---|
| Exercise | Other | B |
| Supportive Care | Other | A |
Primary outcome
The primary endpoint is the mean SF36 physical component summary (PCS) score for subjects in each study Arm after 12 weeks.
6 secondary outcomes
Difference in musculoskeletal symptoms as measured by VAS and NCIC-CTC toxicity criteria.
Global QOL: As measured by SF36 and VAS composite scores at each scheduled follow up visit (Baseline, weeks 4,8,12,24,36,48). See Appendix B for instruments.
Hot Flashes: A hot flash scale will be given to subjects to complete at each scheduled follow up visit (baseline, week 4,8,12,24,36,48). Severity and frequency of hot flashes will be compared between the exercise and control groups at each time point
Arm Circumferences: Arm circumferences will be measured for all subjects on both arms as described in Appendix D at each study follow up visit except weeks 4, 8, and 36.
Bone Mineral Density.
Body Mass Weight, in kilograms, will be recorded for all subjects at baseline and at weeks 4,8,12,24,36, and 48 week visits.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
Related trials for Musculoskeletal Symptoms
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
Multiple Sclerosis Spasticity
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis
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.
Hagen Kennecke, MD principal investigator
BC Cancer Agency Vancouver Centre
Caroline Lohrisch, MD principal investigator
BC Cancer Agency - Vancouver Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise and Supportive Care in people with Musculoskeletal Symptoms, run by British Columbia Cancer Agency at 2 sites in Canada.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
The primary endpoint is the mean SF36 physical component summary (PCS) score for subjects in each study Arm after 12 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 25 Aug 2014.