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

Primary Purpose

Rectal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
for excise, nutrition consultant, nutrition supplement and psychologic intervention.
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rectal Cancer focused on measuring rectal cancer, concurrent chemoradiotherapy, sarcopenia, multimodal rehabilitation

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

multimodal rehabilitation group

Arm Description

no multimodal rehabilitation

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

Outcomes

Primary Outcome Measures

Sarcopenia assessment with muscle power
Assessment with Grip strength(Kg)
Sarcopenia assessment with muscle power
Assessment with Grip strength(Kg)
Sarcopenia assessment with muscle power
Assessment with Grip strength(Kg)
Sarcopenia assessment with speed
Assessment with speed(m/s)
Sarcopenia assessment with speed
Assessment with speed(m/s)
Sarcopenia assessment with speed
Assessment with speed(m/s)
Sarcopenia assessment with DXA
Assessment with DXA(g/cm2)
Sarcopenia assessment with DXA
Assessment with DXA(g/cm2)
Sarcopenia assessment with abdominal CT
Assessment with ASM/heigh2(Kg/m2) of L3 level
Sarcopenia assessment with abdominal CT
Assessment with ASM/heigh2(Kg/m2) of L3 level
Nutrition assessment with albuminemia
albumin level in serum
Nutrition assessment with albuminemia
albumin level in serum
Nutrition assessment with albuminemia
albumin level in serum
Nutrition assessment with pre-albuminemia
pre-albumin level in serum
Nutrition assessment with pre-albuminemia
pre-albumin level in serum
Nutrition assessment with pre-albuminemia
pre-albumin level in serum
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)
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)
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)
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
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
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
Harris Benedict Equation
Total Daily Energy Expenditure
Harris Benedict Equation
Total Daily Energy Expenditure
Harris Benedict Equation
Total Daily Energy Expenditure

Secondary Outcome Measures

Full Information

First Posted
November 29, 2022
Last Updated
December 27, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05664607
Brief Title
Sarcopenia and Multimodal Rehabilitation on the Prognosis of Rectal Cancer Patients Receiving CCRT
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectal cancer, concurrent chemoradiotherapy, sarcopenia, multimodal rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
no multimodal rehabilitation
Arm Title
multimodal rehabilitation group
Arm Type
Experimental
Arm Description
include excise, nutrition consultant, nutrition supplement and psychologic intervention.
Intervention Type
Other
Intervention Name(s)
for excise, nutrition consultant, nutrition supplement and psychologic intervention.
Intervention Description
for excise, nutrition consultant, nutrition supplement and psychologic intervention.
Primary Outcome Measure Information:
Title
Sarcopenia assessment with muscle power
Description
Assessment with Grip strength(Kg)
Time Frame
baseline
Title
Sarcopenia assessment with muscle power
Description
Assessment with Grip strength(Kg)
Time Frame
1.5 months later
Title
Sarcopenia assessment with muscle power
Description
Assessment with Grip strength(Kg)
Time Frame
3 months later
Title
Sarcopenia assessment with speed
Description
Assessment with speed(m/s)
Time Frame
baseline
Title
Sarcopenia assessment with speed
Description
Assessment with speed(m/s)
Time Frame
1.5 months later
Title
Sarcopenia assessment with speed
Description
Assessment with speed(m/s)
Time Frame
3 months later
Title
Sarcopenia assessment with DXA
Description
Assessment with DXA(g/cm2)
Time Frame
baseline
Title
Sarcopenia assessment with DXA
Description
Assessment with DXA(g/cm2)
Time Frame
3 months later
Title
Sarcopenia assessment with abdominal CT
Description
Assessment with ASM/heigh2(Kg/m2) of L3 level
Time Frame
baseline
Title
Sarcopenia assessment with abdominal CT
Description
Assessment with ASM/heigh2(Kg/m2) of L3 level
Time Frame
3 months later
Title
Nutrition assessment with albuminemia
Description
albumin level in serum
Time Frame
baseline
Title
Nutrition assessment with albuminemia
Description
albumin level in serum
Time Frame
1.5 months later
Title
Nutrition assessment with albuminemia
Description
albumin level in serum
Time Frame
3 months later
Title
Nutrition assessment with pre-albuminemia
Description
pre-albumin level in serum
Time Frame
baseline
Title
Nutrition assessment with pre-albuminemia
Description
pre-albumin level in serum
Time Frame
1.5 months later
Title
Nutrition assessment with pre-albuminemia
Description
pre-albumin level in serum
Time Frame
3 months later
Title
Nutrition assessment with PGSGA
Description
patient-generated subjective global assessment Scale (Total score 0~9 ;score 1-3 Good nutritional intake. score 4-8 Moderate malnutrition. score >9Severe malnutrition)
Time Frame
baseline
Title
Nutrition assessment with PGSGA
Description
patient-generated subjective global assessment Scale (Total score 0~9 ;score 1-3 Good nutritional intake. score 4-8 Moderate malnutrition. score >9Severe malnutrition)
Time Frame
1.5 months later
Title
Nutrition assessment with PGSGA
Description
patient-generated subjective global assessment Scale (Total score 0~9 ;score 1-3 Good nutritional intake. score 4-8 Moderate malnutrition. score >9Severe malnutrition)
Time Frame
3 months later
Title
Psychological assessment
Description
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
Time Frame
baseline
Title
Psychological assessment
Description
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
Time Frame
1.5 months later
Title
Psychological assessment
Description
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
Time Frame
3 months later
Title
Harris Benedict Equation
Description
Total Daily Energy Expenditure
Time Frame
baseline
Title
Harris Benedict Equation
Description
Total Daily Energy Expenditure
Time Frame
1.5 months later
Title
Harris Benedict Equation
Description
Total Daily Energy Expenditure
Time Frame
3 months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wan-Hsiang Hu
Phone
886-975056227
Email
gary.hu0805@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan-Hsiang Hu
Organizational Affiliation
Chang Gung Memorial Hospital,Kaohsiung, Taiwan, 833
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan

12. IPD Sharing Statement

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

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