Flexible versus Standard Aerobic Training Dosing in Primary Breast Cancer: A Randomized and Response-Adapted Trial

原发性乳腺癌的灵活与标准有氧训练剂量：一项随机且适应反应的试验

• 批准号: 10708044
• 负责人: Jessica Scott
• 金额: $ 70.86万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-21 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10708044
• 关键词: Address; Adherence; Adverse event; Aerobic; Aerobic Exercise; Attenuated; Biometry; Breast Cancer Patient; Breast Oncology; Cancer Etiology; Cardiopulmonary; Clinical; Common Terminology Criteria for Adverse Events; Data; Dose; Ensure; Exercise; Exercise Test; Frequencies; Impairment; Individual; Investigation; Knowledge; Maintenance; Malignant Neoplasms; Memorial Sloan-Kettering Cancer Center; Morbidity - disease rate; Newly Diagnosed; Oncology; Oxygen Consumption; Patient Outcomes Assessments; Patient Schedules; Patients; Pharmaceutical Preparations; Phase; Population; Qualifying; Quality of life; Random Allocation; Randomized; Recovery; Regimen; Research; Research Personnel; Risk; Safety; Schedule; Severities; Structure; Symptoms; Testing; Translations; Treatment Efficacy; Walking; Work; attenuation; cancer care; cancer initiation; cancer therapy; cardiorespiratory fitness; chemotherapy; clinical care; clinical implementation; conventional dosing; design; digital; efficacy evaluation; exercise intensity; flexibility; improved; instrument; malignant breast neoplasm; mortality; multidisciplinary; patient oriented; primary endpoint; randomized trial; response; secondary endpoint; translational potential; treadmill; treatment adherence; treatment as usual; trial comparing

PROJECT SUMMARY/ABSTRACT Chemotherapy for primary breast cancer causes significant declines in cardiorespiratory fitness (CRF) predisposing patients to increased symptom burden and increased risk of morbidity and mortality from cancer and non-cancer conditions. Randomized trials demonstrate aerobic training (AT) is feasible during chemotherapy for primary breast cancer and attenuates treatment-induced impairments in CRF. However, our recent findings indicate that even with AT during and after chemotherapy, CRF remains substantially below normative values, and less than 25% of patients have a clinically meaningful CRF response. Increasing the dose of AT substantially increases CRF response; however, higher AT doses are associated with lower AT adherence. Thus, use of a conventional dose-response design wherein patients are assigned to fixed doses is likely imprudent considering lower fixed AT doses will result in underdosing in some patients, and poor adherence in others. A more patient- centered approach used in drug trials is flexible dosing, where the dose is escalated for each patient as tolerated. There have been no trials directly assessing the efficacy of flexible AT dosing on CRF in any cancer setting. To address this fundamental knowledge gap in exercise-oncology research, the objective of this study is to compare the effects of flexible versus standard fixed AT dosing and response-adapted AT on CRF response. In this randomized trial, a total of 140 inactive (<90 mins of moderate-intensity exercise/wk) patients with primary breast cancer scheduled to initiate chemotherapy will be randomly allocated (1:1) to Flexible dosing: Individual AT doses escalated; or Standard fixed dosing: 90 mins/week for ~32 weeks (during and after chemotherapy). Patients who do not respond (<3.50 ml/kg/min CRF improvement) at 32 weeks will complete 20 weeks of extended flexible dosing AT. We will address 3 specific aims: AIM 1: Compare the effects of flexible versus standard dosing on CRF response rate. AIM 2: Ascertain the effects on adherence, safety, and patient-reported outcomes. AIM 3: Evaluate the effects of extended AT in CRF non-responders. IMPACT: This study challenges the current dogma that all patients respond equally to a fixed AT dose and will be the first to evaluate flexible AT dosing in any cancer population. Receiving cancer treatment is not a qualifying condition for structured AT and, as such, AT is not currently considered a standard aspect of cancer management. We anticipate the proposed trial will directly address an unmet clinical need by identifying the AT regimen that maximizes CRF response rate and, if successful, findings from this investigation will help guide the AT regimen for translation to clinical care.

项目总结/文摘