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

Rectal Cancer Clinical Trial

Official title:

The Impact of Sarcopenia and the Effect of Multimodal Rehabilitation on the Prognosis of Rectal Cancer Patients Receiving Concurrent Chemoradiotherapy- Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05664607
• Other study ID #: 202200748A3
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Sarcopenia

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 all — Click 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