Exercise Testing for Early Stage Breast Cancer Patients Receiving Radiation Treatment



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer, Other Indications
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:18 - 80
Updated:1/31/2019
Start Date:July 2016
End Date:July 2020

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Pilot Study for Assessment of Exercise Capacity in Breast Cancer Patients With Radiotherapy-Related Fatigue

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.


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
We found this trial at
7
sites
500 Westchester Avenue
Harrison, New York 10604
Phone: 212-639-6828
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Phone: 212-639-6828
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650 Commack Road
Commack, New York 11725
Phone: 212-639-6828
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Commack, NY
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480 Red Hill Road
Middletown, New Jersey 07748
Phone: 212-639-6828
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225 Summit Avenue
Montvale, New Jersey 07645
Phone: 212-639-6828
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Beryl McCormick, MD
Phone: 212-639-6828
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1275 York Avenue
Rockville Centre, New York 11570
Phone: 212-639-6828
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Rockville Centre, NY
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