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Clinical Trial Summary

Forty adult women 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 treatments, 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 under the supervision of a dietitian with caloric content equivalent to 50% of measured energy requirements and low carbohydrate content for the 72 hours prior to each chemotherapy. Tumor outcomes will be assessed via CT scan (tumor size), MRI (novel marker of tumor regression) and venipuncture (circulating tumor cells, and a breast cancer marker), while symptoms and quality of life will be assessed via questionnaire before, during and after up to six chemotherapy treatments of a consistent treatment protocol. Progression-free and overall survival will be tracked for two years after diagnosis.


Clinical Trial 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, 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. Forty patients will be randomly assigned to an acute intervention consisting of both aerobic exercise and caloric restriction administered acutely prior to each of six chemotherapy treatments, or to usual care.

Approach: Participants will include adult women with metastatic breast cancer with measurable pulmonary, visceral, liver, or lymphatic 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 under the supervision of a dietitian with caloric content equivalent to 50% of measured energy requirements and low carbohydrate content for the 72 hours prior to each chemotherapy. This acute intervention does not lead to long-term nutritional imbalances or weight loss. Exercise intensity and meals will be individualized to participant abilities and preferences. Tumor outcomes will be assessed via CT scan (tumor size), MRI (novel marker of tumor regression) and venipuncture (circulating tumor cells, and a breast cancer marker), while symptoms and quality of life will be assessed via questionnaire before, during and after up to six chemotherapy treatments of a consistent treatment protocol. Progression-free and overall survival will be tracked for two years after diagnosis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03795493
Study type Interventional
Source University of Alberta
Contact Claire Trottier, BSc
Phone 7804927820
Email ctrottie@ualberta.ca
Status Not yet recruiting
Phase N/A
Start date January 14, 2019
Completion date December 31, 2021

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