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

December 27, 2022 updated by: Wan-Hsiang Hu, Chang Gung Memorial Hospital

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sarcopenia assessment with muscle power
Time Frame: baseline
Assessment with Grip strength(Kg)
baseline
Sarcopenia assessment with muscle power
Time Frame: 1.5 months later
Assessment with Grip strength(Kg)
1.5 months later
Sarcopenia assessment with muscle power
Time Frame: 3 months later
Assessment with Grip strength(Kg)
3 months later
Sarcopenia assessment with speed
Time Frame: baseline
Assessment with speed(m/s)
baseline
Sarcopenia assessment with speed
Time Frame: 1.5 months later
Assessment with speed(m/s)
1.5 months later
Sarcopenia assessment with speed
Time Frame: 3 months later
Assessment with speed(m/s)
3 months later
Sarcopenia assessment with DXA
Time Frame: baseline
Assessment with DXA(g/cm2)
baseline
Sarcopenia assessment with DXA
Time Frame: 3 months later
Assessment with DXA(g/cm2)
3 months later
Sarcopenia assessment with abdominal CT
Time Frame: baseline
Assessment with ASM/heigh2(Kg/m2) of L3 level
baseline
Sarcopenia assessment with abdominal CT
Time Frame: 3 months later
Assessment with ASM/heigh2(Kg/m2) of L3 level
3 months later
Nutrition assessment with albuminemia
Time Frame: baseline
albumin level in serum
baseline
Nutrition assessment with albuminemia
Time Frame: 1.5 months later
albumin level in serum
1.5 months later
Nutrition assessment with albuminemia
Time Frame: 3 months later
albumin level in serum
3 months later
Nutrition assessment with pre-albuminemia
Time Frame: baseline
pre-albumin level in serum
baseline
Nutrition assessment with pre-albuminemia
Time Frame: 1.5 months later
pre-albumin level in serum
1.5 months later
Nutrition assessment with pre-albuminemia
Time Frame: 3 months later
pre-albumin level in serum
3 months later
Harris Benedict Equation
Time Frame: baseline
Total Daily Energy Expenditure
baseline
Harris Benedict Equation
Time Frame: 1.5 months later
Total Daily Energy Expenditure
1.5 months later
Harris Benedict Equation
Time Frame: 3 months later
Total Daily Energy Expenditure
3 months later
Nutrition assessment with PGSGA
Time Frame: baseline

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
Time Frame: 1.5 months later

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
Time Frame: 3 months later

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
Time Frame: baseline

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
Time Frame: 1.5 months later

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
Time Frame: 3 months later

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Wan-Hsiang Hu, Chang Gung Memorial Hospital,Kaohsiung, Taiwan, 833

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

November 30, 2025

Study Completion (Anticipated)

November 30, 2025

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 27, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202200748A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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