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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.

项目总结/摘要随机试验表明，有氧训练（AT）可以减轻治疗引起的生理功能障碍，和心理社会的结果。然而，无论具体影响癌症治疗的耐受性在很大程度上是未知的。为了解决这一基本知识差距，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局新辅助治疗（TNT）。在这项2期随机试验中，共有216例LARC非活动患者计划将随机分配（1：1：1比例）接受：90分钟/周、150分钟/周或300分钟/周从治疗前到术前（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。目的2：评价AT对血液功能的剂量效应。目的 3：探讨AT对肿瘤临床结局的剂量反应。拟议的研究直接涉及一个未得到满足的通过首次测试AT对多种治疗相关结局的剂量反应效应，在接受TNT治疗的LARC患者中。接受癌症治疗不是运动疗法的合格条件因此，锻炼目前并不被认为是癌症治疗的标准方面。因此如果这项研究的成功发现也将改变癌症运动疗法的临床模式通过增加越来越多的证据支持AT整合到标准的临床癌症护理中。的该补充项目的总体目标是提供学士后研究培训，通过利用评估化疗耐受性的母临床试验，为候选人提供指导计划在LARC患者中。拟议的研究项目将通过以下方式直接促进和扩大母基金使用相对剂量强度综合评价用于确定化疗耐受性的方法。这一多元化补充还将支持职业发展计划，这是专门围绕候选人的临床和研究兴趣，并旨在提供技能，知识和经验： (1)实现拟开展研究的科学目标;（2）实现候选人的短期职业目标入学并成功完成医学院的学习;（3）实现候选人的长期职业目标成为一名临床科学家补充的目的是解决国家卫生研究院的目标，促进多样性，科学研究，并将大大提高候选人的职业发展在学术医学，只有不到5%的人是西班牙裔。