Overview

This trial is active, not recruiting.

Conditions malignant neoplasm, postmenopausal
Treatments exercise intervention, laboratory biomarker analysis, questionnaire administration
Sponsor OHSU Knight Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date September 2012
End date October 2016
Trial size 481 participants
Trial identifier NCT01635413, CPC-12080-LX, IRB00008560, MR00045870, NCI-2012-01141, P30CA069533, R01CA163474

Summary

This research is being done to compare the physical and quality of life benefits of two different types of exercise- tai chi versus strength training- for female cancer survivors who have had chemotherapy. Each exercise- tai chi and strength training- will be compared to participants in a group that performs flexibility and relaxation exercises, which is expected to have different benefits than either tai chi or strength training.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Patients attend strength training classes for 1 hour 2 days per week.
exercise intervention
Undergo strength training classes
laboratory biomarker analysis
Optional correlative studies
questionnaire administration
Complete Health History Questionnaire
(Experimental)
Patients attend tai chi classes for 1 hour 2 days per week.
exercise intervention
Undergo tai chi classes
laboratory biomarker analysis
Optional correlative studies
questionnaire administration
Complete Health History Questionnaire
(Active Comparator)
Patients attend supervised stretching and relaxation classes for 1 hour 2 days per week.
exercise intervention
Undergo stretching and relaxation classes
laboratory biomarker analysis
Optional correlative studies
questionnaire administration
Complete Health History Questionnaire

Primary Outcomes

Measure
Benefits of treatment after completion of structured training
time frame: Up to 6 months after completion of study treatment
Muscle strength and postural stability as mediators between interventions and falls
time frame: Up to 6 months after completion of study treatment
Total number of falls per participant in strength training and tai chi arms compared to control
time frame: Up to 6 months after completion of study treatment

Secondary Outcomes

Measure
Effectiveness of interventions in breast cancer survivors (BCS) compared with women with other cancers
time frame: Up to 6 months after completion of study treatment
Reduction in injurious falls, defined as any fall that resulted in fractures, head injuries, sprains, bruises, scrapes, or serious joint injuries, or in a participant seeking outside medical attention, in patients with at least 1 previous fall
time frame: Up to 6 months after completion of study treatment

Eligibility Criteria

Female participants from 50 years up to 75 years old.

Inclusion Criteria: - Diagnosed with stage I-III cancer other than cancers of the brain or spinal cord (confirmed by patient self-report on the Health History Questionnaire; if patient is unable to confirm either the site of her cancer or that her stage of cancer is < stage IV, we will send a letter to her physician to confirm this criterion) - Completed chemotherapy > 3 months prior to enrollment and no concurrent adjuvant therapy other than hormone manipulation therapy for breast cancer (confirmed by patient self-report on the Health History Questionnaire; if patient is unable to confirm whether or not she completed chemotherapy 3 months prior to enrollment, we will send a letter to her physician to confirm eligibility on this criterion) - Postmenopausal (confirmed by self-report on the Health History Questionnaire; menopausal status could also be confirmed by a recent [< 6 months from enrollment] laboratory report documenting serum follicle-stimulating hormone [FSH] > 30 mIU/ml and/or serum estradiol < 30 pg/ml) - Currently underactive (< 60 minutes of moderate intensity exercise per week in the last month) (confirmed by self-report on the Health History Questionnaire) Exclusion Criteria: - Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent (confirmed by the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone) - A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise (confirmed by self-report on the Health History Questionnaire, and by physician clearance; if in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible)

Additional Information

Official title Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)
Principal investigator Kerri Winters-Stone
Description PRIMARY OBJECTIVES: I. Compare the relative efficacy of tai chi and strength training to prevent falls in female cancer survivors. II. Determine the mechanism by which tai chi and strength training each reduces the risk of falls. III. Determine how well the benefits of each intervention persist after structured training stops. SECONDARY OBJECTIVES: I. Quantify and compare the relative efficacy of tai chi and resistance exercise on biomarkers common to both cancer progression and cardiovascular disease (CVD) in women cancer survivors. (Optional ancillary study) II. Quantify and compare the relative efficacy of tai chi and resistance exercise on biomarkers unique to CVD in women cancer survivors. (Optional ancillary study) III. Determine the influence of initial and changes in adiposity on changes in biomarkers from exercise. (Optional ancillary study) IV. Explore the effects of exercise training on a biomarker of accelerated aging in women cancer survivors. (Optional ancillary study) OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients attend strength training classes for 1 hour 2 days per week. ARM II: Patients attend tai chi classes for 1 hour 2 days per week. ARM III: Patients attend supervised stretching and relaxation classes for 1 hour 2 days per week. In all arms, treatment continues for 6 months. After completion of study treatment, patients are followed up for 6 months.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by OHSU Knight Cancer Institute.
Location data was received from the National Cancer Institute and was last updated in June 2016.