Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Progressive Stretching; Behavioral: Linear Aerobic Training; Behavioral: Nonlinear Aerobic Training; Other: Cardiopulmonary exercise test (CPET); Other: Blood draws

• Registration Number: NCT01186367
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to compare the effects of 3 different approaches to exercise training in women with early stage breast cancer who have completed all primary treatments (except hormone therapy, if appropriate). Prior research in women with early stage breast cancer has shown that some treatments may have an adverse impact on physical fitness levels leading to feelings of fatigue and poor quality of life. Supervised exercise training has been shown to reduce some of these side-effects. However, all the exercise programs have followed essentially the same approach. This study is designed to see if a different approach to exercise training is more effective than the conventional approach currently in use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-19
• Study First Posted: 2010-08-23
• Study Start: 2010-11-11
• Primary Completion: 2023-05-17
• Study Completion: 2023-05-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 174

Inclusion Criteria

• Aged 45-80 years

• Female

• Has been diagnosed with early-stage breast cancer

• Post-menopausal, defined as :

• Age ≥ 45 with no menses for at least 2 years

• Chemically induced menopause through ovarian suppression, as determined by the primary oncologist

• An interval of at least one year, but no more than five years, following the full completion of primary therapy for malignant disease. Primary therapy is defined as:

  • Surgery plus radiation
  • Surgery plus chemotherapy
  • Surgery plus trastuzumab
  • Surgery plus hormone therapy Note: For patients who receive hormone therapy following surgery, the definition of one-year post-completion of therapy is defined by the surgery date. Patients who are currently receiving hormone therapy are eligible for enrollment.

• Weight of < 205 kgs

• ECOG status of 0 or 1

• Life expectancy ≥ 6 months

• Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week.

• Exercise intolerance defined by a VO2peak below that predicted for sedentary age and sex-matched individuals as defined in Appendix H.

• Willing to be randomized to one of the study arms

• Able to complete an acceptable baseline CPET, in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator.

• Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:

  • Achieving a plateau in oxygen consumption, concurrent with an increase in power output;
  • A respiratory exchange ratio ≥ 1.10;
  • Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]);
  • Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.

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Exclusion Criteria

• Any of the following absolute contraindications to cardiopulmonary exercise testing:

  • Acute myocardial infarction within 3-5 days of any planned study procedures;
  • Unstable angina;
  • Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
  • Recurrent syncope;
  • Active endocarditis;
  • Acute myocarditis or pericarditis;
  • Symptomatic severe aortic stenosis;
  • Uncontrolled heart failure;
  • Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
  • Thrombosis of lower extremities;
  • Suspected dissecting aneurysm;
  • Uncontrolled asthma;
  • Pulmonary edema;
  • Respiratory failure;
  • Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis);

• Presence of any other concurrent, actively treated malignancy

• History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)

• Presence of metastatic disease

• Room air desaturation at rest ≤ 85%

• Mental impairment leading to inability to cooperate

• Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Nonlinear Aerobic Training	Cardiopulmonary exercise test (CPET)	The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.
Progressive Stretching Group (Attention control)	Progressive Stretching	The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).
Linear Aerobic Training	Blood draws	The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.
Linear Aerobic Training	Cardiopulmonary exercise test (CPET)	The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.
Nonlinear Aerobic Training	Blood draws	The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.
Progressive Stretching Group (Attention control)	Cardiopulmonary exercise test (CPET)	The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).
Progressive Stretching Group (Attention control)	Blood draws	The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes).
Linear Aerobic Training	Linear Aerobic Training	The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline.
Nonlinear Aerobic Training	Nonlinear Aerobic Training	The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint.

Primary Outcome Measures

Name	Time	Method
To compare the effect of high-intensity to moderate-intensity aerobic training, relative to attention-control, on peak oxygen consumption.	3 time-points	VO2 or peak oxygen consumption will be measured at 3 time-points. Baseline, mid-point (8 weeks), and post-intervention (16 weeks).

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States