Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer (DREAM)
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|ClinicalTrials.gov Identifier: NCT03795493|
Recruitment Status : Not yet recruiting
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Short-term diet and exercise intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Diet Restriction and Exercise-induced Adaptations in Metastatic Breast Cancer|
|Estimated Study Start Date :||January 14, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Intervention Group
Standard chemotherapy treatment and oncology care plus short-term diet and exercise 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 treatments 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.
No Intervention: Control Group
Standard chemotherapy treatment and oncology care.
- Tumor size [ Time Frame: 0-6 weeks before the first chemotherapy treatment and 1-4 weeks after the last chemotherapy treatment ]Percent change in tumor size measured by computerized tomography.
- Tumor response to therapy by magnetic resonance imaging [ Time Frame: 0-6 weeks before the first chemotherapy treatment and 1-4 weeks after the last chemotherapy treatment ]Magnetic resonance imaging (MRI) derived water apparent diffusion coefficient within the tumor
- Tumor response to therapy by circulating blood biomarkers [ Time Frame: 0-6 weeks before the first chemotherapy treatment and 1-4 weeks after the last chemotherapy treatment ]Circulating blood cancer antigen 27.29 (CA 27.29)
- Patient-reported treatment symptoms [ Time Frame: 0-6 weeks before the first chemotherapy treatment, at the mid-point of study participation, and 1-4 weeks after the last chemotherapy treatment ]Patient-reported treatment symptoms assessed using the Rotterdam Symptom Checklist
- Self reported quality of life [ Time Frame: 0-6 weeks before the first chemotherapy treatment, at the mid-point of study participation, and 1-4 weeks after the last chemotherapy treatment ]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.
- Progression-free survival [ Time Frame: Two years after study enrollment ]Average survival time extracted from Cancer Control Alberta's electronic database
- Overall survival [ Time Frame: Two years after study enrollment ]Average survival time extracted from Cancer Control Alberta's electronic database
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795493
|Contact: Claire Trottier, BScemail@example.com|
|Contact: Amy Kirkham, PhD||(780)firstname.lastname@example.org|
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2E1|
|Principal Investigator:||Carla Prado, PhD||University of Alberta|
|Principal Investigator:||Richard Thompson, PhD||University of Alberta|