Exercise Testing for Early Stage Breast Cancer Patients Receiving Radiation Treatment

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02836093

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

6.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Breast Cancer Fatigue	Behavioral: FACIT-Fatigue 52-point questionnaire

Study Design

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 :

Jul 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

evaluations/assessments

Behavioral: FACIT-Fatigue 52-point questionnaire

Outcome Measures

Primary Outcome Measures

fatigue measurement using the 13-item FACIT-fatigue scale [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

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge (Consent only)	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (Consent only)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Consent only)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Commack (Consent only)	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (Consent only)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	Memorial Sloan Kettering Rockville Centre (Consent only)	Rockville Centre	New York	United States	11570