Randomized Anastrozole Exercise Trial

NCT00519883 | Unknown Phase 3

• 1 other identifier: RAE Study
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Musculoskeletal Symptoms

Keywords

Anastrozole; Exercise

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

• 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.

Study Arms (2)

A

ACTIVE COMPARATOR

Arm A: Standard Supportive Care (no supervised exercise)

Other: Supportive Care

B

EXPERIMENTAL

Arm B: Exercise Intervention

Other: Exercise

Interventions

Exercise OTHER

B

Supportive Care OTHER

A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (2)

BC Cancer Agency Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BC Cancer Agency Vancouver Island

Victoria, British Columbia, V8R 6V5, Canada

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Palliative Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Hagen Kennecke, MD

  BC Cancer Agency Vancouver Centre

  PRINCIPAL INVESTIGATOR

• Caroline Lohrisch, MD

  BC Cancer Agency - Vancouver Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2007
• First Posted: August 23, 2007
• Study Start: December 1, 2007
• Primary Completion: July 1, 2010
• Last Updated: August 25, 2014

Record last verified: 2014-08

Locations

CA (2)