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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03795493
Other study ID # HREBA.CC-18-0657
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 23, 2019
Est. completion date July 28, 2024

Study information

Verified date January 2024
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


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 most available treatments. As such, 5-year survival rate for metastatic breast cancer is only 22%. One mechanism for resistance to cancer therapies and promotion of metastasis in solid tumors is that their vascular system is impaired causing diminished delivery of systemic therapy and oxygen. Furthermore, toxicity can be quite high with metastatic regimens, which can limit the dose received. Both diet and exercise have been used to attenuate treatment toxicity, but the promising preclinical evidence showing their potential to enhance chemotherapy efficacy and survival has not been studied in humans. For example, a single bout of aerobic exercise substantially increased tumor blood flow and oxygen delivery, suggesting that chemotherapy delivery to the tumor would be enhanced. Short periods of fasting or caloric restriction also appear to be safe and effective strategies to inhibit tumor growth and enhance chemotherapy efficacy, while also promoting resistance to chemotherapy in healthy cells. Furthermore, combining aerobic exercise and caloric restriction can elicit synergistic effects on outcomes relevant to cancer, including body composition, aerobic fitness, fasting insulin and glucose, insulin-like growth factor, and tumor promoter pathways. Study Design: With preclinical proof-of-principle and clinical safety and feasibility of each intervention independently established, this study will be a phase II, two-arm, single blind, randomized controlled trial. Fifty patients will be randomly assigned to an acute intervention consisting of both caloric restriction administered acutely prior to and aerobic exercise during each treatment of six chemotherapy cycles, or to usual care. Approach: Participants will include adults with metastatic breast cancer with measurable metastases that will receive intravenous chemotherapy. 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. The diet period will be reduced from 72 to 48 hours when there are <7 days between infusions (ie weekly protocols) to avoid inducing a sustained caloric deficit leading to weight loss. This acute intervention does not lead to long-term nutritional imbalances. Exercise intensity and meals will be individualized to participant abilities and preferences. All participants, regardless of group assignment, will receive a one-time phone consultation with a registered dietitian and a certified exercise physiologist to enhance recruitment and retention. 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Short-term diet and exercise intervention
Participants assigned to the intervention group will perform both the diet and acute exercise interventions. The interventions will be applied prior to up to six chemotherapy cycles of a consistent protocol. The total number of treatments of a given protocol received prior to treatment conclusion is dependent on patient condition and oncologic care preferences.

Locations

Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (3)

Lead Sponsor Collaborator
University of Alberta Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

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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