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RAE: Randomized Anastrozole Exercise Trial

Sponsor
British Columbia Cancer Agency (Other)
Overall Status
Unknown status
CT.gov ID
NCT00519883
Collaborator
(none)
72
Enrollment
2
Locations
2
Arms
36
Patients Per Site

Study Details

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
  • Other: Exercise
  • Other: Supportive Care
 Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2007
Actual Primary Completion Date :
Jul 1, 2010

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

Criteria

Ages Eligible for Study:
18 Years and Older
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

Locations

Site City State Country Postal Code
1 BC Cancer Agency Vancouver Centre Vancouver British Columbia Canada V5Z 4E6
2 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00519883
Other Study ID Numbers:
  • RAE Study
First Posted:
Aug 23, 2007
Last Update Posted:
Aug 25, 2014
Last Verified:
Aug 1, 2014
Keywords provided by British Columbia Cancer Agency
Anastrozole
Exercise

Study Results

No Results Posted as of Aug 25, 2014