Breast Cancer Clinical Trial
— DREAMOfficial title:
Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer
Verified date | January 2024 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 chemotherapy cycles, or to usual care. The aerobic exercise intervention will consist of a single supervised recumbent cycle ergometer session performed concurrent to each chemotherapy infusion. The diet intervention consists of provision of meals freshly prepared in a metabolic kitchen with caloric content equivalent to 50% of measured energy requirements and low carbohydrate content for 48-72 hours prior to each chemotherapy infusion. Tumor outcomes will be assessed via CT scan (tumor size) and MRI (novel marker of tumor regression), while treatment side effects will be assessed by MRI and treatment symptoms and quality of life will be assessed via questionnaire before, during and after up to six chemotherapy cycles of a consistent treatment protocol. Progression-free and overall survival will be tracked for two years after diagnosis.
Status | Active, not recruiting |
Enrollment | 23 |
Est. completion date | July 28, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Left ventricular ejection fraction (%) | MRI-derived left ventricular ejection fraction | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | |
Other | Left ventricular global longitudinal strain (%) | MRI-derived left ventricular global longitudinal strain | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | |
Other | Left ventricular mass (g/m²) | MRI-derived left ventricular mass | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | |
Other | Liver fat fraction (%) | Percent of fat in liver derived by PROFIT1 chemical-shift encoded MRI | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | |
Other | Liver T1 relaxation time (ms) | MRI-derived relaxation time from healthy liver | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | |
Other | Thigh skeletal muscle T1 relaxation time (ms) | MRI-derived skeletal muscle T1 relaxation time at mid-thigh | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | |
Other | Thigh muscle volume (mL) | PROFIT1 chemical-shift encoded MRI of the mid-thigh will be used to assess thigh muscle volume | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | |
Other | Thigh skeletal muscle fat fraction % | Percent of intermuscular fat in thigh muscle derived by PROFIT1 chemical-shift encoded MRI | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | |
Other | Patient-reported treatment symptoms | Patient-reported treatment symptoms assessed using the Rotterdam Symptom Checklist | 0-2 weeks before the first chemotherapy treatment of the first cycle, at each chemotherapy treatment, and 2-3 weeks after the last chemotherapy treatment of the last cycle | |
Other | Self reported quality of life | Quality of life assessed using the total score from the Functional Assessment of Cancer Therapy - Fatigue Questionnaire. Scores can range from 0 - 52 where a high score represents a better quality of life. | 0-2 weeks before the first chemotherapy treatment of the first cycle, at the first chemotherapy treatment of 4th cycle, and 2-3 weeks after the last chemotherapy treatment of the last cycle | |
Other | Fatigue | Fatigue assessed using the total score from the Functional Assessment of Cancer Therapy - Fatigue Questionnaire. Scores can range from 0 - 52 where a high score represents a lower level of fatigue. | 0-2 weeks before the first chemotherapy treatment of the first cycle, at the first chemotherapy treatment of 4th cycle, and 2-3 weeks after the last chemotherapy treatment of the last cycle | |
Other | Progression-free survival (months) | Progression-free survival time extracted from Cancer Control Alberta's electronic database | Two years after study enrollment | |
Other | Overall survival (months) | Overall survival time extracted from Cancer Control Alberta's electronic database | Two years after study enrollment | |
Primary | Tumor size change after 6 cycles (mm) | Change in tumor size measured by computerized tomography after 6 cycles. | 0-6 weeks before the first chemotherapy treatment of the first cycle and 1-4 weeks after the last chemotherapy treatment of the last cycle | |
Secondary | Tumor response to therapy by magnetic resonance imaging (mm²/s) | Magnetic resonance imaging (MRI) derived water apparent diffusion coefficient within the tumor | 0-2 weeks before the first chemotherapy treatment of the first cycle and 2-3 weeks after the last chemotherapy treatment of the last cycle | |
Secondary | Tumor size change after 3 cycles (mm) | Change in tumor size measured by computerized tomography after 3 cycles. | 0-6 weeks before the first chemotherapy treatment of the first cycle and 1-3 weeks after the last chemotherapy treatment of the third cycle |
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