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

NCT01186367 | Completed Results

• 1 other identifier: 15-147
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; Linear Versus Nonlinear Aerobic Training; 15-147

Outcome Measures

Primary Outcomes (3)

• To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.

  VO2 or peak oxygen consumption will be measured at Baseline

  Baseline

• To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.

  VO2 or peak oxygen consumption for nonlinear aerobic training will be measured at mid-point (8 weeks)

  8 weeks

• To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.

  VO2 or peak oxygen consumption will be measured at post-intervention (16 weeks).

  16 weeks

Study Arms (3)

Linear Aerobic Training

EXPERIMENTAL

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.

Behavioral: Linear Aerobic Training; Other: Cardiopulmonary exercise test (CPET); Other: Blood draws

Nonlinear Aerobic Training

EXPERIMENTAL

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.

Behavioral: Nonlinear Aerobic Training; Other: Cardiopulmonary exercise test (CPET); Other: Blood draws

Progressive Stretching Group (Attention control)

EXPERIMENTAL

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).

Behavioral: Progressive Stretching; Other: Cardiopulmonary exercise test (CPET); Other: Blood draws

Interventions

Linear Aerobic Training BEHAVIORAL

The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).

Linear Aerobic Training

Nonlinear Aerobic Training BEHAVIORAL

The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).

Nonlinear Aerobic Training

Progressive Stretching BEHAVIORAL

All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.

Progressive Stretching Group (Attention control)

Cardiopulmonary exercise test (CPET) OTHER

Linear Aerobic Training; Nonlinear Aerobic Training; Progressive Stretching Group (Attention control)

Blood draws OTHER

Complete blood count

Linear Aerobic Training; Nonlinear Aerobic Training; Progressive Stretching Group (Attention control)

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Duke University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (3)

• Scott JM, Thomas SM, Peppercorn JM, Herndon JE 2nd, Douglas PS, Khouri MG, Dang CT, Yu AF, Catalina D, Ciolino C, Capaci C, Michalski MG, Eves ND, Jones LW. Effects of Exercise Therapy Dosing Schedule on Impaired Cardiorespiratory Fitness in Patients With Primary Breast Cancer: A Randomized Controlled Trial. Circulation. 2020 Feb 18;141(7):560-570. doi: 10.1161/CIRCULATIONAHA.119.043483. Epub 2020 Feb 17.

  PMID: 32065769 RESULT

• Michalski M, Rowed K, Lavery JA, Moskowitz CS, Capaci C, Stene G, Edvardsen E, Eves ND, Jones LW, Scott JM. Validity of Estimated Cardiorespiratory Fitness in Patients With Primary Breast Cancer. JACC CardioOncol. 2022 Jun 21;4(2):210-219. doi: 10.1016/j.jaccao.2022.05.003. eCollection 2022 Jun.

  PMID: 35818548 DERIVED

• Jones LW, Douglas PS, Eves ND, Marcom PK, Kraus WE, Herndon JE 2nd, Inman BA, Allen JD, Peppercorn J. Rationale and design of the Exercise Intensity Trial (EXCITE): A randomized trial comparing the effects of moderate versus moderate to high-intensity aerobic training in women with operable breast cancer. BMC Cancer. 2010 Oct 6;10:531. doi: 10.1186/1471-2407-10-531.

  PMID: 20925920 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise Test; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Jessica Scott, PhD
• Organization: Memorial Sloan Kettering Cancer Center

scottj1@mskcc.org

646-888-8093

Study Officials

• Jessica Scott, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: November 11, 2010
• Primary Completion: May 17, 2023
• Study Completion: May 17, 2023
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2024-03

Locations

US (1)