Clinical trial NCT05664607: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectal Cancer
Keywords: rectal cancer
concurrent chemoradiotherapy
sarcopenia
multimodal rehabilitation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Sarcopenia assessment with muscle power
timeFrame: baseline
measure: Sarcopenia assessment with muscle power
timeFrame: 1.5 months later
measure: Sarcopenia assessment with muscle power
timeFrame: 3 months later
measure: Sarcopenia assessment with speed
timeFrame: baseline
measure: Sarcopenia assessment with speed
timeFrame: 1.5 months later
measure: Sarcopenia assessment with speed
timeFrame: 3 months later
measure: Sarcopenia assessment with DXA
timeFrame: baseline
measure: Sarcopenia assessment with DXA
timeFrame: 3 months later
measure: Sarcopenia assessment with abdominal CT
timeFrame: baseline
measure: Sarcopenia assessment with abdominal CT
timeFrame: 3 months later
measure: Nutrition assessment with albuminemia
timeFrame: baseline
measure: Nutrition assessment with albuminemia
timeFrame: 1.5 months later
measure: Nutrition assessment with albuminemia
timeFrame: 3 months later
measure: Nutrition assessment with pre-albuminemia
timeFrame: baseline
measure: Nutrition assessment with pre-albuminemia
timeFrame: 1.5 months later
measure: Nutrition assessment with pre-albuminemia
timeFrame: 3 months later
measure: Nutrition assessment with PGSGA
timeFrame: baseline
measure: Nutrition assessment with PGSGA
timeFrame: 1.5 months later
measure: Nutrition assessment with PGSGA
timeFrame: 3 months later
measure: Psychological assessment
timeFrame: baseline
measure: Psychological assessment
timeFrame: 1.5 months later
measure: Psychological assessment
timeFrame: 3 months later
measure: Harris Benedict Equation
timeFrame: baseline
measure: Harris Benedict Equation
timeFrame: 1.5 months later
measure: Harris Benedict Equation
timeFrame: 3 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital,Kaohsiung, Taiwan, 833
name: Wan-Hsiang Hu
role: PRINCIPAL_INVESTIGATOR
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