To Compare the Effect of Different Nutritional Pathways on Improving Nutritional Status of Esopha… (NCT04199832) | Clinical Trial Compass
CompletedNot Applicable
To Compare the Effect of Different Nutritional Pathways on Improving Nutritional Status of Esophageal Cancer Patients Undergoing Chemoradiotherapy
China156 participantsStarted 2019-12-20
Plain-language summary
This study prospectively recruited esophageal squamous-cell carcinoma patients who received nasogastric tube (NG), gastrostomy feeding and oral intake to compare the changes in nutritional status and quality of life during chemoradiation therapy (CRT).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Pathologically or cytologically proven esophageal squamous cell carcinoma
* Karnofsky performance score(KPS) ≧70
* Concurrent chemoradiotherapy
* Hemoglobin≥90.0g/dL,white blood cell count(WBC)≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times upper limit of normal,bilirubin normal
* Creatinine normal OR creatinine clearance ≥ 60 mL/min
* Patients have good compliance to treatment and follow-up of acceptance
* the functions of the heart, kidney, liver were basically normal, with no chemotherapy and radiotherapy contraindications
Exclusion Criteria:
* Patients with severely bowel function impaired or can not tolerate enteral nutrition
* Patients with serious gastrointestinal obstruction, be unable to take food by mouth and can not / do not want to a feeding tube inserted
* Patients who have severe vomiting, gastrointestinal bleeding, intestinal obstruction
* Patients who have distant metastasis
* The primary tumor or lymph node already received surgical treatment efuse or incapable to sign the informed consent form of participating this trial
What they're measuring
1
Body Weight Change from baseline to the end of treatment
Timeframe: up to 1 month after the treatment
Trial details
NCT IDNCT04199832
SponsorTianjin Medical University Cancer Institute and Hospital