Breast Cancer Clinical Trial

Exercise Testing for Early Stage Breast Cancer Patients Receiving Radiation Treatment

Summary

Many patients receiving radiation therapy for breast cancer experience fatigue although doctors do not fully understand why. The purpose of this study is to test if patients who experience fatigue during radiation treatment for breast cancer have changes in their capability to perform exercise on a treadmill.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Female
ECOG performance status 0 or 1
Medical clearance from attending radiation oncologist or medical oncologist to undergo a symptom-limited CPET
Currently undergoing intact breast radiotherapy for early stage breast cancer (including TisN0, T1N0, T2N0) or has completed intact breast RT in the last 3 months.
Receiving or received a prescribed dose of 4240 cGy in 16 fractions to the whole breast without treatment directed at nodal basins. Patients may also be receiving or have received a boost to the lumpectomy bed at the discretion of the treating physician.
Subjects may be treated in the supine or prone position at the discretion of the treating physician.
Subjects may be treated with or without a deep inspiratory breath hold technique at the discretion of the treating physician.
Identified by the treating radiation oncologist as having significant treatment-related fatigue or minimal treatment-related fatigue and not simply baseline fatigue. A score of "0" on the RTOG fatigue scale will be considered minimal fatigue, while a score of "2" or greater will be considered significant fatigue (moderate fatigue causing difficulty performing some ADLs).

Exclusion Criteria:

Currently undergoing post-mastectomy radiation
Has received chemotherapy previously or has a plan to receive chemotherapy during the timeframe of study assessment.

Any of the following absolute contraindications to CPET, as per American Thoracic Society (ATS) recommendations

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
Room air desaturation at rest ≤ 85%
Respiratory failure
Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
Mental impairment leading to inability to cooperate

Study is for people with:

Breast Cancer

Estimated Enrollment:

45

Study ID:

NCT02836093

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 7 Locations for this study

See Locations Near You

Memoral Sloan Kettering Basking Ridge (Consent only)
Basking Ridge New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent only)
Montvale New Jersey, 07645, United States
Memorial Sloan Kettering Commack (Consent only)
Commack New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Memorial Sloan Kettering Rockville Centre (Consent only)
Rockville Centre New York, 11570, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

45

Study ID:

NCT02836093

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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