Sarcopenia and Multimodal Rehabilitation on the Prognosis of Rectal Cancer Patients Receiving CCRT

NCT ID: NCT05664607

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Investigators use clinical trial to explore the role of sarcopenia and multimodal rehabilitation in prognosis of rectal cancer patients receiving concurrent chemoradiotherapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The impact of sarcopenia and the effect of multimodal rehabilitation will be evaluated in the rectal cancer patients receiving pre-operative concurrent chemoradiotherapy. This is a randomized trial.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

rectal cancer concurrent chemoradiotherapy sarcopenia multimodal rehabilitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

no multimodal rehabilitation

Group Type NO_INTERVENTION

No interventions assigned to this group

multimodal rehabilitation group

include excise, nutrition consultant, nutrition supplement and psychologic intervention.

Group Type EXPERIMENTAL

for excise, nutrition consultant, nutrition supplement and psychologic intervention.

Intervention Type OTHER

for excise, nutrition consultant, nutrition supplement and psychologic intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

for excise, nutrition consultant, nutrition supplement and psychologic intervention.

for excise, nutrition consultant, nutrition supplement and psychologic intervention.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age\>20
* rectal cancer patients receiving concurrent chemoradiotherapy
* agree to join the trial and sign the informed consent form

Exclusion Criteria

* unstable vital sign
* unable to excise
* not suitable after evaluation by Principal Investigator
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wan-Hsiang Hu

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wan-Hsiang Hu

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital,Kaohsiung, Taiwan, 833

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wan-Hsiang Hu

Role: CONTACT

Phone: 886-975056227

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

Lieffers JR, Bathe OF, Fassbender K, Winget M, Baracos VE. Sarcopenia is associated with postoperative infection and delayed recovery from colorectal cancer resection surgery. Br J Cancer. 2012 Sep 4;107(6):931-6. doi: 10.1038/bjc.2012.350. Epub 2012 Aug 7.

Reference Type BACKGROUND
PMID: 22871883 (View on PubMed)

Reisinger KW, van Vugt JL, Tegels JJ, Snijders C, Hulsewe KW, Hoofwijk AG, Stoot JH, Von Meyenfeldt MF, Beets GL, Derikx JP, Poeze M. Functional compromise reflected by sarcopenia, frailty, and nutritional depletion predicts adverse postoperative outcome after colorectal cancer surgery. Ann Surg. 2015 Feb;261(2):345-52. doi: 10.1097/SLA.0000000000000628.

Reference Type BACKGROUND
PMID: 24651133 (View on PubMed)

Choi MH, Oh SN, Lee IK, Oh ST, Won DD. Sarcopenia is negatively associated with long-term outcomes in locally advanced rectal cancer. J Cachexia Sarcopenia Muscle. 2018 Feb;9(1):53-59. doi: 10.1002/jcsm.12234. Epub 2017 Aug 28.

Reference Type BACKGROUND
PMID: 28849630 (View on PubMed)

Nakanishi R, Oki E, Sasaki S, Hirose K, Jogo T, Edahiro K, Korehisa S, Taniguchi D, Kudo K, Kurashige J, Sugiyama M, Nakashima Y, Ohgaki K, Saeki H, Maehara Y. Sarcopenia is an independent predictor of complications after colorectal cancer surgery. Surg Today. 2018 Feb;48(2):151-157. doi: 10.1007/s00595-017-1564-0. Epub 2017 Jul 11.

Reference Type BACKGROUND
PMID: 28699003 (View on PubMed)

Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.

Reference Type BACKGROUND
PMID: 24461239 (View on PubMed)

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

Reference Type BACKGROUND
PMID: 30312372 (View on PubMed)

Bano G, Trevisan C, Carraro S, Solmi M, Luchini C, Stubbs B, Manzato E, Sergi G, Veronese N. Inflammation and sarcopenia: A systematic review and meta-analysis. Maturitas. 2017 Feb;96:10-15. doi: 10.1016/j.maturitas.2016.11.006. Epub 2016 Nov 13.

Reference Type BACKGROUND
PMID: 28041587 (View on PubMed)

Lin JX, Lin JP, Xie JW, Wang JB, Lu J, Chen QY, Cao LL, Lin M, Tu R, Zheng CH, Huang CM, Li P. Prognostic Value and Association of Sarcopenia and Systemic Inflammation for Patients with Gastric Cancer Following Radical Gastrectomy. Oncologist. 2019 Nov;24(11):e1091-e1101. doi: 10.1634/theoncologist.2018-0651. Epub 2019 Mar 25.

Reference Type BACKGROUND
PMID: 30910865 (View on PubMed)

Tessier AJ, Chevalier S. An Update on Protein, Leucine, Omega-3 Fatty Acids, and Vitamin D in the Prevention and Treatment of Sarcopenia and Functional Decline. Nutrients. 2018 Aug 16;10(8):1099. doi: 10.3390/nu10081099.

Reference Type BACKGROUND
PMID: 30115829 (View on PubMed)

Minnella EM, Bousquet-Dion G, Awasthi R, Scheede-Bergdahl C, Carli F. Multimodal prehabilitation improves functional capacity before and after colorectal surgery for cancer: a five-year research experience. Acta Oncol. 2017 Feb;56(2):295-300. doi: 10.1080/0284186X.2016.1268268. Epub 2017 Jan 12.

Reference Type BACKGROUND
PMID: 28079430 (View on PubMed)

Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393.

Reference Type BACKGROUND
PMID: 25076007 (View on PubMed)

Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.

Reference Type BACKGROUND
PMID: 28489682 (View on PubMed)

Hu WH, Chang CD, Liu TT, Chen HH, Hsiao CC, Kang HY, Chuang JH. Association of sarcopenia and expression of interleukin-23 in colorectal cancer survival. Clin Nutr. 2021 Oct;40(10):5322-5326. doi: 10.1016/j.clnu.2021.08.016. Epub 2021 Aug 30.

Reference Type BACKGROUND
PMID: 34536640 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202200748A3

Identifier Type: -

Identifier Source: org_study_id