High-Intensity Interval Training for the Improvement of Cognitive Function in Stage I-III Breast Cancer Patients Undergoing Chemotherapy, The CLARITY Trial

Inclusion Criteria

• Written informed consent prior to any study-related procedures
• Women newly diagnosed with breast cancer; all stages except stage IV
• Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
• The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential must agree to undergo a pregnancy test and to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
• Will receive (neo)adjuvant chemotherapy
• Speak English or Spanish
• Able to provide physician clearance to participate in the exercise program
• Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
• Have not experienced a weight reduction >= 10% within the past 6 months
• Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise/week
• Does not smoke (no smoking during previous 12 months)
• Willing to travel to Dana-Farber Cancer Institute (DFCI) for assessments (54 visits total for those assigned to the exercise group, 6 visits for those assigned to the control group)
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease
• Patients with other active malignancies are ineligible for this study
• Patients with metastatic disease
• Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
• Participates in more than 60 minutes of moderate or vigorous structured exercise/week
• Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise
• Have a pacemaker or any implantable device that are not MRI safe; the Brigham and Women's Hospital (BWH)/DFCI standard MRI screening form
• Is unable to travel to DFCI
• Patients who are pregnant
• Patients with claustrophobia
• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study