Diversity Supplement: Dose-response of aerobic training during total neoadjuvant therapy for locally advanced rectal cancer

多样性补充：局部晚期直肠癌全新辅助治疗期间有氧训练的剂量反应

基本信息

批准号：
10817969
负责人：
Andrea Cercek
金额：
$ 6.94万
依托单位：
SLOAN-KETTERING INST CAN RESEARCH
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-05-01 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10817969
关键词：
Address Adherence Aerobic Exercise Age Anemia Antiemetics Apoptosis Attenuated Biological Biological Assay Blinded Cancer Control Cancer Patient Case Report Form Cessation of life Chemotherapy and/or radiation Clinical Clinical Trials Common Terminology Criteria for Adverse Events Complete Blood Count Correlative Study Data Development Plans Diagnosis Disease-Free Survival Dose Electronics Enrollment Erythrocytes Evaluation Event Exercise Exercise Therapy F2-Isoprostanes Fatigue Female Flow Cytometry Generations Goals Guidelines Hematology Hematopoietic stem cells Hemoglobin Hispanic Home Impairment In complete remission Incidence Individual Induction of Apoptosis Investigation Knowledge Local Therapy Malignant Neoplasms Mass Spectrum Analysis Medicine Mentorship Methods Modeling Modification Neoadjuvant Therapy Neutropenia Oncologist Oncology Operative Surgical Procedures Outcome Parents Pathologic Patient Outcomes Assessments Patient Schedules Patients Pharmaceutical Preparations Pharmacotherapy Phase Phase II/III Trial Physiological Pilot Projects Postbaccalaureate Postoperative Complications Proliferating Qualifying Quality of life Random Allocation Reactive Oxygen Species Recovery Rectal Cancer Regimen Reporting Research Research Project Grants Research Training Safety Sample Size Schedule Scientific Advances and Accomplishments Scientist Standardization Structure Survival Rate Techniques Testing Time Toxic effect Translating Treatment-related toxicity United States National Institutes of Health Walking Work adjudication cancer care cancer initiation cancer survival cancer therapy cancer type career career development chemoradiation chemotherapy clinical candidate clinical practice design digital evidence base exercise intensity experience improved interest male malignant breast neoplasm medical schools meetings neutrophil parent grant parent project patient population point of care preclinical study primary endpoint programs progression risk psychosocial randomized trial real time monitoring response sex skills standard of care treadmill treatment planning tumor

项目摘要

PROJECT SUMMARY/ABSTRACT Randomized trials demonstrate aerobic training (AT) attenuates treatment-induced impairments in physiological and psychosocial outcomes in a broad number of cancer patient populations. However, whether AT specifically impacts the tolerability of cancer treatment is largely unknown. To address this fundamental knowledge gap in exercise-oncology research, the objective of this study is to evaluate the dose-response of AT on treatment tolerability and related outcomes in patients with locally advanced rectal cancer (LARC) initiating total neoadjuvant therapy (TNT). In this phase 2 randomized trial, a total of 216 inactive patients with LARC scheduled to initiate TNT will be randomly allocated (1:1:1 ratio) to receive: 90 mins/week, 150 mins/week, or 300 mins/week from pre-treatment to pre-surgery (~32 weeks). We will address 3 specific aims: AIM 1: Determine dose- response of AT on TNT treatment tolerability. AIM 2: Evaluate AT dose-response on hematological function. AIM 3: Explore AT dose-response on tumor clinical outcomes. The proposed study directly addresses an unmet clinical need by testing, for the first time, the dose-response effects of AT on multiple treatment-related outcomes in patients with LARC receiving TNT. Receiving cancer treatment is not a qualifying condition for exercise therapy and, as such, exercise is not currently considered a standard aspect of cancer management. Therefore, if successful, findings from this investigation will also shift clinical paradigms regarding exercise therapy in cancer by adding to a growing body of evidence supporting integration of AT into standard clinical cancer care. The overall objective of this supplemental project is to provide a post-baccalaureate research training and mentorship program for the candidate by leveraging the parent clinical trial evaluating chemotherapy tolerability in patients with LARC. The proposed research project will directly contribute to and expand the parent grant by comprehensively evaluating methods used to determine chemotherapy tolerability using relative dose intensity. This Diversity Supplement will also support a career development plan that was specifically designed around the candidate’s clinical and research interests, and is intended to provide the skills, knowledge, and experience to: (1) accomplish the scientific aims of the proposed research; (2) realize the candidate’s short term career goals of enrolling in and successfully completing medical school; and (3) achieve the candidate’s long term career goal of becoming a clinician-scientist. The aims of the supplement address the NIH goals of promoting diversity in scientific research and will strongly enhance the candidate’s career development within academic medicine, where less than 5% of individuals identify as Hispanic.

项目概要/摘要随机试验表明有氧训练 (AT) 可减轻治疗引起的生理损伤然而，无论是 AT 特异，还是广大癌症患者群体的心理社会结果。癌症治疗的耐受性的影响在很大程度上尚不清楚。运动肿瘤学研究，本研究的目的是评估 AT 对治疗的剂量反应局部晚期直肠癌 (LARC) 患者的耐受性和相关结果新辅助治疗 (TNT) 在这项 2 期随机试验中，总共安排了 216 名不活跃的 LARC 患者。启动 TNT 将被随机分配（1:1:1 比例）接收：90 分钟/周、150 分钟/周或 300 分钟/周从治疗前到手术前（约 32 周），我们将解决 3 个具体目标：目标 1：确定剂量- AT 对 TNT 治疗耐受性的反应 AIM 2：评估 AT 对血液学功能的剂量反应。 3：探索 AT 对肿瘤临床结果的剂量反应拟议的研究直接解决了未满足的问题。通过首次测试 AT 对多种治疗相关结果的剂量反应效应来满足临床需求接受 TNT 治疗的 LARC 患者不符合运动疗法的条件。因此，运动目前不被认为是癌症治疗的标准方面。成功，这项研究的结果也将改变癌症运动疗法的临床范式越来越多的证据支持将 AT 纳入标准临床癌症护理。该补充项目的总体目标是提供学士学位后研究培训和通过利用评估化疗耐受性的母体临床试验为候选人提供指导计划拟议的研究项目将直接贡献并扩大家长资助。使用相对剂量强度综合评估用于确定化疗耐受性的方法。该多元化补充品还将支持专门围绕以下方面设计的职业发展计划：候选人的临床和研究兴趣，旨在提供技能、知识和经验： (1) 完成拟议研究的科学目标； (2) 实现候选人的短期职业目标注册并成功完成医学院学业；以及 (3) 实现候选人的长期职业目标成为临床医生科学家的目标该增刊的目标是实现 NIH 促进多样性的目标。科学研究并将大力促进候选人在学术医学领域的职业发展，其中只有不到 5% 的人认为自己是西班牙裔。