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.

项目摘要/摘要随机试验表明有氧训练（AT）减弱了治疗诱导的生理障碍和大量癌症患者人群中的社会心理结局。但是，是否专门影响癌症治疗的耐受性在很大程度上未知。解决这个基本知识差距运动肿瘤研究，本研究的目的是评估AT治疗的剂量反应局部晚期直肠癌患者（LARC）的耐受性和相关结局启动了新辅助治疗（TNT）。在此阶段2随机试验中，总共有216名不活跃的LARC计划要启动TNT将被随机分配（1：1：1）要接收：90分钟/周，150分钟/周或300分钟/周从治疗到手术前（〜32周）。我们将解决3个具体目标：目标1：确定剂量 - AT tNT治疗耐受性的响应。 AIM 2：对血液学功能的剂量反应进行评估。目的 3：在肿瘤临床结果时探索剂量反应。拟议的研究直接解决了未完成的通过测试AT对多个治疗相关结果的剂量反应效应，临床需求首次测试在LARC接受TNT的患者中。接受癌症治疗不是运动治疗的合格条件因此，目前尚未将运动视为癌症管理的标准方面。因此，如果成功的调查结果还将改变有关癌症运动治疗的临床范例通过增加越来越多的证据体系，支持AT在标准临床癌症护理中的整合。这这个补充项目的总体目的是提供后库后的研究培训和通过利用父母临床试验评估化学疗法耐受性，用于候选人的属于候选人计划在LARC患者中。拟议的研究项目将直接促进并扩大父母的赠款全面评估用于使用相对剂量强度来确定化学疗法耐受性的方法。这种多样性补充剂还将支持一项职业发展计划，该计划是专门设计的候选人的临床和研究兴趣，旨在为：（1）实现拟议研究的科学目标；（2）意识到候选人的短期职业目标入学并成功完成医学院；（3）实现候选人的长期职业目标成为临床科学家。补充剂的目的解决了NIH促进多样性的目标科学研究，将大力增强候选人在学术医学中的职业发展，不到5％的个体将其视为西班牙裔。