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Investigators use clinical trial to explore the role of sarcopenia and multimodal rehabilitation in prognosis of rectal cancer patients receiving concurrent chemoradiotherapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | no multimodal rehabilitation | |
| multimodal rehabilitation group | Experimental | include excise, nutrition consultant, nutrition supplement and psychologic intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| for excise, nutrition consultant, nutrition supplement and psychologic intervention. | Other | for excise, nutrition consultant, nutrition supplement and psychologic intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sarcopenia assessment with muscle power | Assessment with Grip strength(Kg) | baseline |
| Sarcopenia assessment with muscle power | Assessment with Grip strength(Kg) | 1.5 months later |
| Sarcopenia assessment with muscle power | Assessment with Grip strength(Kg) | 3 months later |
| Sarcopenia assessment with speed | Assessment with speed(m/s) | baseline |
| Sarcopenia assessment with speed | Assessment with speed(m/s) | 1.5 months later |
| Sarcopenia assessment with speed | Assessment with speed(m/s) | 3 months later |
| Sarcopenia assessment with DXA | Assessment with DXA(g/cm2) | baseline |
| Sarcopenia assessment with DXA | Assessment with DXA(g/cm2) | 3 months later |
| Sarcopenia assessment with abdominal CT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wan-Hsiang Hu | Contact | 886-975056227 | gary.hu0805@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wan-Hsiang Hu | Chang Gung Memorial Hospital,Kaohsiung, Taiwan, 833 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Kaohsiung City | 833 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22871883 | Background | 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. | |
| 24651133 | Background | 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. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Assessment with ASM/heigh2(Kg/m2) of L3 level
| baseline |
| Sarcopenia assessment with abdominal CT | Assessment with ASM/heigh2(Kg/m2) of L3 level | 3 months later |
| Nutrition assessment with albuminemia | albumin level in serum | baseline |
| Nutrition assessment with albuminemia | albumin level in serum | 1.5 months later |
| Nutrition assessment with albuminemia | albumin level in serum | 3 months later |
| Nutrition assessment with pre-albuminemia | pre-albumin level in serum | baseline |
| Nutrition assessment with pre-albuminemia | pre-albumin level in serum | 1.5 months later |
| Nutrition assessment with pre-albuminemia | pre-albumin level in serum | 3 months later |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Harris Benedict Equation | Total Daily Energy Expenditure | baseline |
| Harris Benedict Equation | Total Daily Energy Expenditure | 1.5 months later |
| Harris Benedict Equation | Total Daily Energy Expenditure | 3 months later |
| 28849630 | Background | 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. |
| 28699003 | Background | 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. |
| 24461239 | Background | 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. |
| 30312372 | Background | 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. |
| 28041587 | Background | 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. |
| 30910865 | Background | 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. |
| 30115829 | Background | 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. |
| 28079430 | Background | 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. |
| 25076007 | Background | 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. |
| 28489682 | Background | 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. |
| 34536640 | Background | 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |