Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer

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.

Sex

All

Minimum age

18 Years

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

• DERIVEDKirkham AA, King K, Joy AA, Pelletier AB, Mackey JR, Young K, Zhu X, Meza-Junco J, Basi SK, Hiller JP, Brkin T, Michalowski B, Pituskin E, Paterson DI, Courneya KS, Thompson RB, Prado CM. Rationale and design of the Diet Restriction and Exercise-induced Adaptations in Metastatic breast cancer (DREAM) study: a 2-arm, parallel-group, phase II, randomized control trial of a short-term, calorie-restricted, and ketogenic diet plus exercise during intravenous chemotherapy versus usual care. BMC Cancer. 2021 Oct 10;21(1):1093. doi: 10.1186/s12885-021-08808-2. PMID 34629067