NCT03795493Completed
Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 4 Dec 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 26 Nov 2018
- Start date
- 23 Apr 2019
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University of Alberta
- Diseases
- Metastatic breast cancer
- NCT number
- NCT03795493
What you commit to
- Study type: Interventional
- Participants enrolled: 23
- From 23 Apr 2019 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diabetes;
- Severe food allergies;
- History of eating disorder (diagnosed or self-reported);
- Unable to provide informed consent (i.e. cognitive impairment);
Lab values
- Bilirubin \>30 umol/L;
- Creatinine \>120 umol/L;
Other
- 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;
- Strict diet restrictions including vegetarian or vegan;
- Supplemental oxygen requirement;
- Uncontrolled pleural effusions (oncologists approval if pleural effusions exists and are controlled);
- Pregnant;
- Contraindications to 3T MRI for research purposes
Who the study is looking for
- 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;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.