Exercise Testing for Early Stage Breast Cancer Patients Receiving Radiation Treatment

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836093
• Other study ID #: 16-941
• Status: Completed
• Start date: July 13, 2016
• Est. completion date: December 27, 2023

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 27, 2023
• Est. primary completion date: December 27, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Intervention

Behavioral:
• FACIT-Fatigue 52-point questionnaire

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent only)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (Consent only)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent only)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent only)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Rockville Centre (Consent only)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue measurement using the 13-item FACIT-fatigue scale	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

External Links

•   Memorial Sloan Kettering Cancer Center