医学
适应
临床终点
卵巢癌
化疗
妇科肿瘤学
新辅助治疗
癌症
随机对照试验
肿瘤科
内科学
乳腺癌
人文学科
哲学
作者
Éric Lambaudie,Cécile Bannier,Braticevic,Charlène Villaron,Goetgheluck,Christophe Zemmour,Jean‐Marie Boher,Patrick Ben Soussan,Jihane Pakradouni,C. Brun,Leonor Lopez Almeida,Patricia Marino
出处
期刊:International Journal of Gynecological Cancer
[BMJ]
日期:2020-12-01
卷期号:31 (6): 920-924
被引量:9
标识
DOI:10.1136/ijgc-2020-002128
摘要
Patients undergoing neoadjuvant chemotherapy before surgery for advanced ovarian cancer may have impaired functional capacity, nutritional status, and emotional well-being.TRAINING-01 aims to determine if a connected pre-habilitation program during neoadjuvant chemotherapy for patients treated for an advanced ovarian cancer will improve physical capacity before major abdomino-pelvic surgery.A pre-habilitation program during neoadjuvant chemotherapy will bring a fitter patient to surgery and will decrease treatment morbidity and improve oncological outcomes.This study is a prospective, multi-center, phase III study. The pre-habilitation program consists of providing multi-dimensional support during neoadjuvant chemotherapy using connected devices. The control group will receive usual care.Eligible patients will be women with International Federation of Gynecology and Obstetrics stage III-IV advanced ovarian cancer undergoing neoadjuvant chemotherapy. Patients must be able to perform a cardiopulmonary exercise test.The primary endpoint will be the comparison of the variation in maximum oxygen uptake (VO2 max) between baseline and surgery in the pre-habilitation group and control groups.136 patients (68 per arm) will be recruited to demonstrate a medium standardized effect d=0.5 in the variations of VO2 max between baseline and surgery.The duration of the study includes 24 months of recruitment and 5 years of follow up. We anticipate reporting primary endpoint results in 2024.TRAINING-01-IPC 2018-039 (NCT04451369).
科研通智能强力驱动
Strongly Powered by AbleSci AI