Status:
COMPLETED
Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater th...
Eligibility Criteria
Inclusion
- Breast cancer diagnosis (stage 0-III)
- Body mass index of 25mg/k2 or greater
- Actively being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center
- Able and willing to participate in nutrition counseling at Maroone Cancer Center
- Able (cleared by participant's primary oncologist) and willing to perform cardiopulmonary exercise testing
- Participants must have the ability to understand and the willingness to sign a written informed consent document
- Performance status 0 or 1 as per ECOG scale \[see Appendix IV\]
Exclusion
- Body mass index below 25kg/m2
- No prior history of breast cancer
- History of metastatic disease
- Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center
- Unable or unwilling to participate in nutrition counseling at Maroone Cancer Center
- Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Participants actively undergoing chemotherapy, immunotherapy or radiation treatment. However, participants currently taking hormonal therapy, such as selective estrogen receptor modulators (SERMS), or aromatase inhibitors, may be included in the study.
Key Trial Info
Start Date :
January 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2024
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04365569
Start Date
January 6 2021
End Date
May 16 2024
Last Update
September 29 2025
Active Locations (1)
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1
Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center
Weston, Florida, United States, 33331