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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05664607
Other study ID # 202200748A3
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date November 30, 2025

Study information

Verified date December 2022
Source Chang Gung Memorial Hospital
Contact Wan-Hsiang Hu
Phone 886-975056227
Email gary.hu0805@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date November 30, 2025
Est. primary completion date November 30, 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Age Ageing. 2019 Jul 1;48(4):601. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Sarcopenia assessment with muscle power Assessment with Grip strength(Kg) baseline
Primary Sarcopenia assessment with muscle power Assessment with Grip strength(Kg) 1.5 months later
Primary Sarcopenia assessment with muscle power Assessment with Grip strength(Kg) 3 months later
Primary Sarcopenia assessment with speed Assessment with speed(m/s) baseline
Primary Sarcopenia assessment with speed Assessment with speed(m/s) 1.5 months later
Primary Sarcopenia assessment with speed Assessment with speed(m/s) 3 months later
Primary Sarcopenia assessment with DXA Assessment with DXA(g/cm2) baseline
Primary Sarcopenia assessment with DXA Assessment with DXA(g/cm2) 3 months later
Primary Sarcopenia assessment with abdominal CT Assessment with ASM/heigh2(Kg/m2) of L3 level baseline
Primary Sarcopenia assessment with abdominal CT Assessment with ASM/heigh2(Kg/m2) of L3 level 3 months later
Primary Nutrition assessment with albuminemia albumin level in serum baseline
Primary Nutrition assessment with albuminemia albumin level in serum 1.5 months later
Primary Nutrition assessment with albuminemia albumin level in serum 3 months later
Primary Nutrition assessment with pre-albuminemia pre-albumin level in serum baseline
Primary Nutrition assessment with pre-albuminemia pre-albumin level in serum 1.5 months later
Primary Nutrition assessment with pre-albuminemia pre-albumin level in serum 3 months later
Primary Nutrition assessment with PGSGA patient-generated subjective global assessment Scale (Total score 0~9
;score 1-3 Good nutritional intake. score 4-8 Moderate malnutrition. score >9Severe malnutrition)
baseline
Primary Nutrition assessment with PGSGA patient-generated subjective global assessment Scale (Total score 0~9
;score 1-3 Good nutritional intake. score 4-8 Moderate malnutrition. score >9Severe malnutrition)
1.5 months later
Primary Nutrition assessment with PGSGA patient-generated subjective global assessment Scale (Total score 0~9
;score 1-3 Good nutritional intake. score 4-8 Moderate malnutrition. score >9Severe malnutrition)
3 months later
Primary Psychological assessment Taiwanese Depression Questionnaire (TDQ)Total score 0-54; score >8 emotionally stable ;Score 9 ~ 14 Pay attention to emotional changes Score 15 ~ 18 pressure load reaches the critical point; Score 19-28 It is recommended to find a professional institution or medical unit assistance
;Scores 29 or more must find professional medical units to get involved
baseline
Primary Psychological assessment Taiwanese Depression Questionnaire (TDQ)Total score 0-54; score >8 emotionally stable ;Score 9 ~ 14 Pay attention to emotional changes Score 15 ~ 18 pressure load reaches the critical point; Score 19-28 It is recommended to find a professional institution or medical unit assistance
;Scores 29 or more must find professional medical units to get involved
1.5 months later
Primary Psychological assessment Taiwanese Depression Questionnaire (TDQ)Total score 0-54; score >8 emotionally stable ;Score 9 ~ 14 Pay attention to emotional changes Score 15 ~ 18 pressure load reaches the critical point; Score 19-28 It is recommended to find a professional institution or medical unit assistance
;Scores 29 or more must find professional medical units to get involved
3 months later
Primary Harris Benedict Equation Total Daily Energy Expenditure baseline
Primary Harris Benedict Equation Total Daily Energy Expenditure 1.5 months later
Primary Harris Benedict Equation Total Daily Energy Expenditure 3 months later
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