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Exercise Testing for Early Stage Breast Cancer Patients Receiving Radiation Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836093
Recruitment Status : Active, not recruiting
First Posted : July 18, 2016
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
Breast Cancer Fatigue Behavioral: FACIT-Fatigue 52-point questionnaire

Study Design
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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study for Assessment of Exercise Capacity in Breast Cancer Patients With Radiotherapy-Related Fatigue
Actual Study Start Date : July 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

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Groups and Cohorts
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Group/Cohort Intervention/treatment
evaluations/assessments Behavioral: FACIT-Fatigue 52-point questionnaire


Outcome Measures
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Primary Outcome Measures :
  1. fatigue measurement using the 13-item FACIT-fatigue scale [ Time Frame: 1 year ]
    Fatigue will be assessed using the 13-item FACIT-fatigue scale for the assessment of fatigue in cancer patients.24 The FACIT-Fatigue is a validated questionnaire that was originally developed for the precise evaluation of fatigue levels in cancer patients with anemia. It consists of 13 questions using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). It has been used frequently in the clinical trial setting (please see appendix 1). Responses to each question are added with equal weight to obtain a total score. The range of possible scores is 0-52, with 0 corresponding to the highest level of fatigue and 52 corresponding to the lowest level of fatigue.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836093


Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Rockville Centre (Consent only)
Rockville Centre, New York, United States, 11570
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Beryl McCormick, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02836093    
Other Study ID Numbers: 16-941
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Exercise
Radiation Treatment
16-941
Additional relevant MeSH terms:
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Breast Neoplasms
Fatigue
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases