Status:
COMPLETED
Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Canadian Cancer Society (CCS)
Canadian Institutes of Health Research (CIHR)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Fifty patients with metastatic breast cancer will be randomly assigned to an acute intervention consisting of both aerobic exercise and caloric restriction administered acutely prior to each of six ch...
Detailed Description
Despite major advances in recent decades in treatment for early stage breast cancer leading to an 89% 5-year survival rate, metastatic breast cancer is still considered incurable due to resistance to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03795493
Start Date
April 23 2019
End Date
December 31 2023
Last Update
December 4 2024
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1