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

Not Applicable

Not yet recruiting

• Conditions: Rectal Cancer
• Interventions: Other: for excise, nutrition consultant, nutrition supplement and psychologic intervention.

• Registration Number: NCT05664607
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study First Submitted: 2022-11-29
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2022-12-23
• Last Update Submitted: 2022-12-27
• Last Update Posted: 2022-12-29
• Study Start: 2023-01-01
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multimodal rehabilitation group	for excise, nutrition consultant, nutrition supplement and psychologic intervention.	include excise, nutrition consultant, nutrition supplement and psychologic intervention.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan