NCT05664607

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

2.9 years

First QC Date

November 29, 2022

Last Update Submit

December 27, 2022

Conditions

Rectal Cancer

Keywords

rectal cancerconcurrent chemoradiotherapysarcopeniamultimodal rehabilitation

Outcome Measures

Primary Outcomes (25)

  • 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

    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

Study Arms (2)

control group

NO INTERVENTION

no multimodal rehabilitation

multimodal rehabilitation group

EXPERIMENTAL

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

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

Interventions

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

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

multimodal rehabilitation group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • unstable vital sign
  • unable to excise
  • not suitable after evaluation by Principal Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Related Publications (13)

  • 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.

    PMID: 22871883BACKGROUND

  • 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.

    PMID: 24651133BACKGROUND

  • 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.

    PMID: 28849630BACKGROUND

  • 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.

    PMID: 28699003BACKGROUND

  • 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.

    PMID: 24461239BACKGROUND

  • 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.

    PMID: 30312372BACKGROUND

  • 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.

    PMID: 28041587BACKGROUND

  • 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.

    PMID: 30910865BACKGROUND

  • 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.

    PMID: 30115829BACKGROUND

  • 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.

    PMID: 28079430BACKGROUND

  • 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.

    PMID: 25076007BACKGROUND

  • 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.

    PMID: 28489682BACKGROUND

  • 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.

    PMID: 34536640BACKGROUND

MeSH Terms

Conditions

Rectal NeoplasmsSarcopenia

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Wan-Hsiang Hu

    Chang Gung Memorial Hospital,Kaohsiung, Taiwan, 833

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wan-Hsiang Hu

CONTACT

886-975056227gary.hu0805@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 23, 2022

Study Start

January 1, 2023

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

December 29, 2022

Record last verified: 2022-12

Locations

TW(1)