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Randomized Anastrozole Exercise Trial (RAE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00519883
First received: August 22, 2007
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00519883     History of Changes
Other Study ID Numbers: RAE Study
Study First Received: August 22, 2007
Last Updated: August 21, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by British Columbia Cancer Agency:
Anastrozole
Exercise

Additional relevant MeSH terms:
Anastrozole
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014