CARE: Protocol of a randomised trial evaluating the feasibility of preoperative intentional weight loss to support postoperative recovery in patients with excess weight and colorectal cancer

被引:6
作者
Koutoukidis, Dimitrios A. [1 ,2 ]
Jebb, Susan A. [1 ]
Foster, Claire [3 ]
Wheatstone, Pete [4 ]
Horne, Alison [5 ]
Hill, T. Martyn [5 ]
Taylor, Amy [5 ]
Realpe, Alba [6 ,7 ]
Achana, Felix [1 ]
Buczacki, Simon J. A. [2 ,8 ]
机构
[1] Univ Oxford, Nuffield Dept Primary Care Hlth Sci, Oxford, England
[2] Oxford Biomed Res Ctr, NIHR, Oxford, England
[3] Univ Southampton, Ctr Psychosocial Res Canc, CentRIC Hlth Sci, Southampton, England
[4] Patient & Publ Involvement Representat, Leeds, England
[5] Univ Oxford, Nuffield Dept Surg Sci, Surg Intervent Trials Unit, Oxford, England
[6] Univ Bristol, Bristol Med Sch, Populat Hlth Sci, Bristol, England
[7] Bristol Biomed Res Ctr, NIHR, Bristol, England
[8] Univ Oxford, Nuffield Dept Surg Sci, Oxford, England
关键词
colorectal cancer; diet; morbidity; prehabilitation; surgery; weight loss; QUALITY-OF-LIFE; PHYSICAL FUNCTION; SURGERY; OUTCOMES; DIET; ASSOCIATION; SURVIVORS; FITNESS; OBESITY; MUSCLE;
D O I
10.1111/codi.16687
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
AimExcess weight increases the risk of morbidity following colorectal cancer surgery. Weight loss may improve morbidity, but it is uncertain whether patients can follow an intensive weight loss intervention while waiting for surgery and there are concerns about muscle mass loss. The aim of this trial is to assess the feasibility of intentional weight loss in this setting and determine progression to a definitive trial. MethodsCARE is a prospectively registered, multicentre, feasibility, parallel, randomised controlled trial with embedded evaluation and optimisation of the recruitment process. Participants with excess weight awaiting curative colorectal resection for cancer are randomised 1:1 to care as usual or a low-energy nutritionally-replete total diet replacement programme with weekly remote behavioural support by a dietitian. Progression criteria will be based on the recruitment, engagement, adherence, and retention rates. Data will be collected on the 30-day postoperative morbidity, the typical primary outcome of prehabilitation trials. Secondary outcomes will include, among others, length of hospital stay, health-related quality of life, and body composition. Qualitative interviews will be used to understand patients' experiences of and attitudes towards trial participation and intervention engagement and adherence. ConclusionCARE will evaluate the feasibility of intensive intentional weight loss as prehabilitation before colorectal cancer surgery. The results will determine the planning of a definitive trial.
引用
收藏
页码:1910 / 1920
页数:11
相关论文
共 72 条
[61]   Could Preoperative Unintended Weight Loss Predispose to Postoperative Thrombosis in Patients Undergoing Colorectal Cancer Surgery? An Analysis of the NSQIP Data [J].
Temraz, Sally ;
Tamim, Hani ;
Mailhac, Aurelie ;
Nassar, Farah ;
Moukalled, Nour ;
Jamali, Faek ;
Taher, Ali .
JOURNAL OF THE AMERICAN COLLEGE OF NUTRITION, 2021, 40 (02) :141-147
[62]   Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial [J].
Turrado, Victor ;
Guzman, Yoelimar ;
Jimenez-Lillo, Julio ;
Villegas, Eduardo ;
de Lacy, Francisco B. ;
Blanch, Jordi ;
Balibrea, Jose M. ;
Lacy, Antonio .
SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES, 2021, 35 (07) :4042-4047
[63]   Colorectal cancer survivors only marginally change their overall lifestyle in the first 2 years following diagnosis [J].
van Zutphen, Moniek ;
Boshuizen, Hendriek C. ;
Kok, Dieuwertje E. ;
van Baar, Harm ;
Geijsen, Anne J. M. R. ;
Wesselink, Evertine ;
Winkels, Renate M. ;
van Halteren, Henk K. ;
de Wilt, Johannes H. W. ;
Kampman, Ellen ;
van Duijnhoven, Franzel J. B. .
JOURNAL OF CANCER SURVIVORSHIP, 2019, 13 (06) :956-967
[64]   Low plasma vitamin D is associated with adverse colorectal cancer survival after surgical resection, independent of systemic inflammatory response [J].
Vaughan-Shaw, P. G. ;
Zgaga, L. ;
Ooi, L. Y. ;
Theodoratou, E. ;
Timofeeva, M. ;
Svinti, V. ;
Walker, M. ;
O'Sullivan, F. ;
Ewing, A. ;
Johnston, S. ;
Din, F. V. N. ;
Campbell, H. ;
Farrington, S. M. ;
Dunlop, M. G. .
GUT, 2020, 69 (01) :103-+
[65]   Weight Loss, Exercise, or Both and Physical Function in Obese Older Adults [J].
Villareal, Dennis T. ;
Chode, Suresh ;
Parimi, Nehu ;
Sinacore, David R. ;
Hilton, Tiffany ;
Armamento-Villareal, Reina ;
Napoli, Nicola ;
Qualls, Clifford ;
Shah, Krupa .
NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (13) :1218-1229
[66]   Impact of prehabilitation on objectively measured physical activity levels in elective surgery patients: a systematic review [J].
Wagnild, Janelle M. ;
Akowuah, Enoch ;
Maier, Rebecca H. ;
Hancock, Helen C. ;
Kasim, Adetayo .
BMJ OPEN, 2021, 11 (09)
[67]   ESPEN guideline: Clinical nutrition in surgery [J].
Weimann, Arved ;
Braga, Marco ;
Carli, Franco ;
Higashiguchi, Takashi ;
Huebner, Martin ;
Klek, Stanislaw ;
Laviano, Alessandro ;
Ljungqvist, Olle ;
Lobo, Dileep N. ;
Martindale, Robert ;
Waitzberg, Dan L. ;
Bischoff, Stephan C. ;
Singer, Pierre .
CLINICAL NUTRITION, 2017, 36 (03) :623-650
[68]   Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer [J].
Whistance, R. N. ;
Conroy, T. ;
Chie, W. ;
Costantini, A. ;
Sezer, O. ;
Koller, M. ;
Johnson, C. D. ;
Pilkington, S. A. ;
Arraras, J. ;
Ben-Josef, E. ;
Pullyblank, A. M. ;
Fayers, P. ;
Blazeby, J. M. .
EUROPEAN JOURNAL OF CANCER, 2009, 45 (17) :3017-3026
[69]   Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened, Eligible, Approached, Randomised) framework [J].
Wilson, Caroline ;
Rooshenas, Leila ;
Paramasivan, Sangeetha ;
Elliott, Daisy ;
Jepson, Marcus ;
Strong, Sean ;
Birtle, Alison ;
Beard, David J. ;
Halliday, Alison ;
Hamdy, Freddie C. ;
Lewis, Rebecca ;
Metcalfe, Chris ;
Rogers, Chris A. ;
Stein, Robert C. ;
Blazeby, Jane M. ;
Donovan, Jenny L. .
TRIALS, 2018, 19
[70]   The association of medical and demographic characteristics with sarcopenia and low muscle radiodensity in patients with nonmetastatic colorectal cancer [J].
Xiao, Jingjie ;
Caan, Bette J. ;
Feliciano, Elizabeth M. Cespedes ;
Meyerhardt, Jeffrey A. ;
Kroenke, Candyce H. ;
Baracos, Vickie E. ;
Weltzien, Erin ;
Kwan, Marilyn L. ;
Alexeeff, Stacey E. ;
Castillo, Adrienne L. ;
Prado, Carla M. .
AMERICAN JOURNAL OF CLINICAL NUTRITION, 2019, 109 (03) :615-625