Randomized Anastrozole Exercise Trial

Musculoskeletal Symptoms Clinical Trial

— RAE  

Official title:

Randomized Anastrozole Exercise Trial (The RAE Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00519883
• Other study ID #: RAE Study
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 22, 2007
• Last updated: August 21, 2014
• Start date: December 2007

Study information

• Verified date: August 2014
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Musculoskeletal Symptoms

Intervention

Other:
• Exercise

• Supportive Care

Locations

Country	Name	City	State
Canada	BC Cancer Agency Vancouver Centre	Vancouver	British Columbia
Canada	BC Cancer Agency Vancouver Island	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the mean SF36 physical component summary (PCS) score for subjects in each study Arm after 12 weeks.
Secondary	Difference in musculoskeletal symptoms as measured by VAS and NCIC-CTC toxicity criteria.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	Bone Mineral Density.
Secondary	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.