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Randomized Anastrozole Exercise Trial (RAE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by British Columbia Cancer Agency.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
British Columbia Cancer Agency Identifier:
First received: August 22, 2007
Last updated: August 21, 2014
Last verified: August 2014

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.

Condition Intervention Phase
Musculoskeletal Symptoms Other: Exercise Other: Supportive Care Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Anastrozole Exercise Trial (The RAE Study)

Resource links provided by NLM:

Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • The primary endpoint is the mean SF36 physical component summary (PCS) score for subjects in each study Arm after 12 weeks.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 72
Study Start Date: December 2007
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Arm A: Standard Supportive Care (no supervised exercise)
Other: Supportive Care
Experimental: B
Arm B: Exercise Intervention
Other: Exercise


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00519883

Canada, British Columbia
BC Cancer Agency Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
BC Cancer Agency Vancouver Island
Victoria, British Columbia, Canada, V8R 6V5
Sponsors and Collaborators
British Columbia Cancer Agency
Principal Investigator: Hagen Kennecke, MD BC Cancer Agency Vancouver Centre
Principal Investigator: Caroline Lohrisch, MD BC Cancer Agency - Vancouver Centre
  More Information

Responsible Party: British Columbia Cancer Agency Identifier: NCT00519883     History of Changes
Other Study ID Numbers: RAE Study
Study First Received: August 22, 2007
Last Updated: August 21, 2014

Keywords provided by British Columbia Cancer Agency:

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on August 18, 2017