Breast Cancer Clinical Trial

Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program

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 than a two-fold increase in mortality compared to women with normal body mass index (BMI). The current standard for weight loss interventions involves in-person counseling. However, this incurs costs related to travel for counseling sessions, potentially limiting program participation, compliance and sustainability.This is a pilot study of an individualized in-person and telephone-based nutrition and exercise counseling program.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

60

Study ID:

NCT04365569

Recruitment Status:

Recruiting

Sponsor:

Case Comprehensive Cancer Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center
Weston Florida, 33331, United States More Info
Elizabeth Stone, MD
Contact
954-659-5840
[email protected]
Elizabeth Stone, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

60

Study ID:

NCT04365569

Recruitment Status:

Recruiting

Sponsor:


Case Comprehensive Cancer Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider