Clinical trial NCT02836093: Exercise Testing for Early Stage Breast Cancer Patients Receiving Radiation Treatment
Official title: Pilot Study for Assessment of Exercise Capacity in Breast Cancer Patients With Radiotherapy-Related Fatigue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Fatigue
Keywords: Exercise
Radiation Treatment
16-941
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-07-18
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are undergoing or have recently completed radiotherapy for breast cancer (in the last 3 months) will be assessed in outpatient clinics of the Radiation Oncology Department of MSKCC. The protocol is available for consenting only at OneMSK Sites Basking Ridge, Rockville Center, Commack, Monmouth and Westchester.

Brief 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.


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

Primary outcomes:
measure: fatigue measurement using the 13-item FACIT-fatigue scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Beryl McCormick, MD
role: PRINCIPAL_INVESTIGATOR
References: