Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT03795493
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of stage IV or metastatic breast cancer;
* Measurable metastases.
* Age \>18
* Starting (or having only received one treatment of) any type of intravenously administered chemotherapy;
* Eastern Cooperative Oncology Group (ECOG) Score \< 3
* Oncologist approval to participate
* Able to communicate and read and understand English;
* Willing and able to adhere to the study interventions and assessments;
Exclusion Criteria:
* Limitations to sustained exercise (including bone metastases in the femur neck);
* Clinical evidence of cachexia (oncologist's discretion, study team will use body mass index \<18.5kg/m² as a flag to highlight concern to treating oncologist);
* Body mass \>109 kg at time of enrollment;
* Diabetes;
* Severe food allergies;
* History of eating disorder (diagnosed or self-reported);
* Strict diet restrictions including vegetarian or vegan;
* Unable to provide informed consent (i.e. cognitive impairment);
* Supplemental oxygen requirement;
* Uncontrolled pleural effusions (oncologists approval if pleural effusions exists and are controlled);
* Bilirubin \>30 umol/L;
* Creatinine \>120 umol/L;
* Pregnant;
* Contraindications to 3T MRI for research purposes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03795493
Study Brief:
Protocol Section:
NCT03795493