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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Other: for excise, nutrition consultant, nutrition supplement and psychologic intervention.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>no multimodal rehabilitation | |
| Experimental: multimodal rehabilitation group<br>include excise, nutrition consultant, nutrition supplement and psychologic intervention. | Other: for excise, nutrition consultant, nutrition supplement and psychologic intervention.<br>* for excise, nutrition consultant, nutrition supplement and psychologic intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal cancer, concurrent chemoradiotherapy, sarcopenia, multimodal rehabilitation