Exercise Testing for Early Stage Breast Cancer Patients Receiving Radiation Treatment

December 28, 2023 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
evaluations/assessments
Behavioral: FACIT-Fatigue 52-point questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Beryl McCormick, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2016

Primary Completion (Actual)

December 27, 2023

Study Completion (Actual)

December 27, 2023

Study Registration Dates

First Submitted

July 14, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (Estimated)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-941

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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