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Randomized Anastrozole Exercise Trial (RAE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00519883
Recruitment Status : Unknown
Verified August 2014 by British Columbia Cancer Agency.
Recruitment status was:  Active, not recruiting
First Posted : August 23, 2007
Last Update Posted : August 25, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Musculoskeletal Symptoms Other: Exercise Other: Supportive Care Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Anastrozole Exercise Trial (The RAE Study)
Study Start Date : December 2007
Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Anastrozole
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A
Arm A: Standard Supportive Care (no supervised exercise)
Other: Supportive Care
Experimental: B
Arm B: Exercise Intervention
Other: Exercise


Outcome Measures

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

Secondary Outcome Measures :
  1. Difference in musculoskeletal symptoms as measured by VAS and NCIC-CTC toxicity criteria.
  2. 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.
  3. 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
  4. 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.
  5. Bone Mineral Density.
  6. 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.

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519883


Locations
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
Investigators
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
ClinicalTrials.gov Identifier: NCT00519883     History of Changes
Other Study ID Numbers: RAE Study
First Posted: August 23, 2007    Key Record Dates
Last Update Posted: August 25, 2014
Last Verified: August 2014

Keywords provided by British Columbia Cancer Agency:
Anastrozole
Exercise

Additional relevant MeSH terms:
Anastrozole
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