Clinical trial NCT04567459: The Effect of Nutrition for the Colorectal Cancer Patients Receiving Chemotherapy-randomized Controlled Study
Official title: The Effect of Nutrition for the Colorectal Cancer Patients Receiving Chemotherapy-randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer
Chemotherapy
Nutrition
Sarcopenia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Hanben Enterprise
First posted: 2020-09-28
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: We use clinical trial to explore the effect of nutrition support in colorectal cancer patients receiving postoperative adjuvant chemotherapy.

Detailed description: Colorectal cancer is the most common cancer in Taiwan. Side effects induced by postoperative adjuvant chemotherapy will affect nutrition status and may delay treatment and affect prognosis. Sarcopenia may be noted in some patients and increase the toxicities of chemotherapy. The studies of intervention include nutrition consultant and treatment like protein, fish oil or Vitamin D supplement. Premium amino acids include multiple amino acids and organic Selenium and have effect in inhibition of tumor proliferation according to colorectal cancer cell and animal experiments.

Eligibility criteria: Inclusion Criteria:

* Age \> 20
* Radical operation for stage III and stage II with high risk colorectal cancer
* Agree to join the trial and sign the informed consent form

Exclusion Criteria:

* Unable to receive chemotherapy
* Unstable vital sign
* Not suitable after evaluation by Principal Investigator

Primary outcomes:
measure: Assessment of adverse event
timeFrame: 2 weeks after chemotherapy
measure: 1)Nutrition assessment
timeFrame: 2 weeks after chemotherapy
measure: 2)Nutrition assessment
timeFrame: 2 weeks after chemotherapy
measure: 1)Sarcopenia assessment muscle power
timeFrame: At 1st cycle of chemotherapy (each cycle is 2 weeks).
measure: 1)Sarcopenia assessment muscle power
timeFrame: At 12th cycle of chemotherapy (each cycle is 2 weeks).
measure: 2)Sarcopenia assessment muscle power
timeFrame: At 1st cycle of chemotherapy (each cycle is 2 weeks).
measure: 2)Sarcopenia assessment muscle power
timeFrame: At 12st cycle of chemotherapy (each cycle is 2 weeks).
measure: 3)Sarcopenia assessment
timeFrame: At 1st cycle of chemotherapy (each cycle is 2 weeks).
measure: 3)Sarcopenia assessment
timeFrame: At 12th cycle of chemotherapy (each cycle is 2 weeks).
measure: 4)Sarcopenia assessment
timeFrame: At 1st cycle of chemotherapy (each cycle is 2 weeks).
measure: 4)Sarcopenia assessment
timeFrame: At 12th cycle of chemotherapy (each cycle is 2 weeks).
measure: 5)Sarcopenia assessment
timeFrame: At 6th cycle of chemotherapy (each cycle is 2 weeks).
measure: 5)Sarcopenia assessment
timeFrame: At 12th cycle of chemotherapy (each cycle is 2 weeks).
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital,Kaohsiung
Study officials:
References:
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