Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer

Official Title

Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer

Summary:

Fifty 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. Tumour outcomes will be assessed via CT scan (tumour size)and MRI (novel marker of tumour 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 treatments of a consistent treatment protocol. Progression-free and overall survival will be tracked for two years after diagnosis.

Trial Description

Primary Outcome:

  • Tumour size
Secondary Outcome:
  • Tumour response to therapy by magnetic resonance imaging
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 tumours 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 tumour blood flow and oxygen delivery, suggesting that chemotherapy delivery to the tumour would be enhanced. Short periods of fasting or caloric restriction also appear to be safe and effective strategies to inhibit tumour 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 tumour 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 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. Tumour outcomes will be assessed via CT scan (tumour size) and MRI (novel marker of tumour regression), 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society