Nutrition and Cancer Outcomes in Shaanxi Chemoradiotherapy
- Conditions
- ChemoradiotherapyCancerNutrition, HealthyOncologyClinical Outcomes
- Registration Number
- NCT06219083
- Lead Sponsor
- Xiaoqin Luo
- Brief Summary
The study investigates the impact of nutritional status on the clinical outcomes of cancer patients in Shaanxi Province undergoing chemoradiotherapy. It focuses on understanding how diet and nutrition affect the effectiveness and side effects of cancer treatments.
- Detailed Description
Study Purpose and Content: The research aims to investigate the nutritional status and trends in cancer patients at different stages of chemoradiotherapy in Shaanxi Province.
Registry Procedures: The study will recruit patients from 20 hospitals across the province, tracking their nutritional status, disease condition, and quality of life through various stages of treatment.
Quality Control: Nutritional assessments are to be conducted at specific intervals, and all research staff are required to undergo training for consistency in data collection and patient evaluation.
Ethical Considerations: The study ensures informed consent from participants and confidentiality of personal information, with approval from the ethics committee of Xi'an Jiaotong University Medical College.
Data Collection and Analysis: Data will be gathered through detailed patient surveys, laboratory tests, and physical measurements, with subsequent analysis to establish a predictive model for cancer patient survival based on nutritional indicators.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- Adults aged 18 years and above
- Pathologically diagnosed with malignant tumors
- Scheduled to undergo radiotherapy and/or chemotherapy
- Clear consciousness, no communication barriers
- Willing to undergo follow-up, not in a near-death condition
- Patients without a pathological diagnosis of malignant tumors
- Patients with AIDS
- Patients with mental or cognitive disorders
- Patients who have undergone organ transplantation
- Patients with a life expectancy less than 12 months
- Pregnant women
- Patients currently participating in other clinical intervention studies
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method BMI through study completion, an average of 1 year BMI was kept at 1 decimal place.
Height through study completion, an average of 1 year The accuracy of the height was 0.5cm, and this value should be noted if there was ascites, systemic edema, and huge tumors.
Weight through study completion, an average of 1 year Weight accuracy to 0.2kg,and this value should be noted if there was ascites, systemic edema, and huge tumors.
- Secondary Outcome Measures
Name Time Method Total Cholesterol 1 year mmol/L
Albumin 1 year g/L
Interleukin-1 (IL-1) 1 year Ug
Creatinine 1 year mmol/L
Platelets 1 year \*10\^9/L
Chemotherapy toxic effects 6 months the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0)
Prealbumin 1 year mg/L
Urea Nitrogen 1 year mmol/L
Triglycerides 1 year mmol/L
Interleukin-6 (IL-6) 1 year Ug
Total Protein 1 year g/L
Glucose 1 year mmol/L
Low-Density Lipoprotein (LDL) Cholesterol 1 year mmol/L
Hemoglobin 1 year \*10\^9/L
Transferrin 1 year g/L
C-reactive Protein 1 year mg/L
Aspartate Aminotransferase (AST) 1 year U/L
Alanine Aminotransferase (ALT) 1 year U/L
Tumor Necrosis Factor-alpha (TNF-α) 1 year nmol/l
Total Bilirubin 1 year umol/L
Direct Bilirubin 1 year umol/L
Neutrophil Count 1 year \*10\^9/L
Lymphocyte Count 1 year \*10\^9/L
High-Density Lipoprotein (HDL) Cholesterol 1 year mmol/L
Leukocytes (White Blood Cells) 1 year \*10\^9/L
Red Blood Cells 1 year \*10\^12/L
Trial Locations
- Locations (1)
Xi 'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China