Clinical trial NCT00519883: Randomized Anastrozole Exercise Trial
Official title: Randomized Anastrozole Exercise Trial (The RAE Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Musculoskeletal Symptoms
Keywords: Anastrozole
Exercise
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2007-08-23
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The primary endpoint is the mean SF36 physical component summary (PCS) score for subjects in each study Arm after 12 weeks.
Secondary outcomes:
measure: Difference in musculoskeletal symptoms as measured by VAS and NCIC-CTC toxicity criteria.
measure: 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.
measure: 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
measure: 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.
measure: Bone Mineral Density.
measure: 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.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer Agency Vancouver Centre
state: British Columbia
city: Victoria
country: Canada
facility: BC Cancer Agency Vancouver Island
state: British Columbia
Study officials:
affiliation: BC Cancer Agency Vancouver Centre
name: Hagen Kennecke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BC Cancer Agency - Vancouver Centre
name: Caroline Lohrisch, MD
role: PRINCIPAL_INVESTIGATOR
References: