Nutrition and Cancer Outcomes in Shaanxi Chemoradiotherapy

Cancer Clinical Trial

Official title:

Impact of Nutritional Status on Clinical Outcomes in Cancer Patients Receiving Chemoradiotherapy in Shaanxi Province

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06219083
• Other study ID #: 2022-1373
• Status: Recruiting
• Start date: November 12, 2020
• Est. completion date: December 1, 2031

Study information

• Verified date: January 2024
• Source: Health Science Center of Xi'an Jiaotong University
• Contact: Xiaoqin Luo, Ph.D
• Phone: +8617791547192
• Email: clyeah[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 1, 2031
• Est. primary completion date: December 1, 2030
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cancer
• Chemoradiotherapy
• Clinical Outcomes
• Neoplasms
• Oncology

Locations

Country	Name	City	State
China	Xi 'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoqin Luo

Country where clinical trial is conducted

China, 

References & Publications (28)

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Loman BR, Luo M, Baggs GE, Mitchell DC, Nelson JL, Ziegler TR, Deutz NE, Matarese LE; NOURISH Study Group. Specialized High-Protein Oral Nutrition Supplement Improves Home Nutrient Intake of Malnourished Older Adults Without Decreasing Usual Food Intake. — View Citation

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Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, — View Citation

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Seo SH, Kim SE, Kang YK, Ryoo BY, Ryu MH, Jeong JH, Kang SS, Yang M, Lee JE, Sung MK. Association of nutritional status-related indices and chemotherapy-induced adverse events in gastric cancer patients. BMC Cancer. 2016 Nov 18;16(1):900. doi: 10.1186/s12 — View Citation

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Tan S, Meng Q, Jiang Y, Zhuang Q, Xi Q, Xu J, Zhao J, Sui X, Wu G. Impact of oral nutritional supplements in post-discharge patients at nutritional risk following colorectal cancer surgery: A randomised clinical trial. Clin Nutr. 2021 Jan;40(1):47-53. doi — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height	The accuracy of the height was 0.5cm, and this value should be noted if there was ascites, systemic edema, and huge tumors.	through study completion, an average of 1 year
Primary	Weight	Weight accuracy to 0.2kg,and this value should be noted if there was ascites, systemic edema, and huge tumors.	through study completion, an average of 1 year
Primary	BMI	BMI was kept at 1 decimal place.	through study completion, an average of 1 year
Secondary	Total Protein	g/L	1 year
Secondary	Albumin	g/L	1 year
Secondary	Prealbumin	mg/L	1 year
Secondary	Transferrin	g/L	1 year
Secondary	C-reactive Protein	mg/L	1 year
Secondary	Glucose	mmol/L	1 year
Secondary	Aspartate Aminotransferase (AST)	U/L	1 year
Secondary	Alanine Aminotransferase (ALT)	U/L	1 year
Secondary	Interleukin-1 (IL-1)	Ug	1 year
Secondary	Tumor Necrosis Factor-alpha (TNF-a)	nmol/l	1 year
Secondary	Creatinine	mmol/L	1 year
Secondary	Urea Nitrogen	mmol/L	1 year
Secondary	Total Bilirubin	umol/L	1 year
Secondary	Direct Bilirubin	umol/L	1 year
Secondary	Total Cholesterol	mmol/L	1 year
Secondary	Triglycerides	mmol/L	1 year
Secondary	High-Density Lipoprotein (HDL) Cholesterol	mmol/L	1 year
Secondary	Low-Density Lipoprotein (LDL) Cholesterol	mmol/L	1 year
Secondary	Interleukin-6 (IL-6)	Ug	1 year
Secondary	Hemoglobin	*10^9/L	1 year
Secondary	Leukocytes (White Blood Cells)	*10^9/L	1 year
Secondary	Neutrophil Count	*10^9/L	1 year
Secondary	Lymphocyte Count	*10^9/L	1 year
Secondary	Red Blood Cells	*10^12/L	1 year
Secondary	Platelets	*10^9/L	1 year
Secondary	Chemotherapy toxic effects	the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0)	6 months

External Links

•   World Health Organization. Cancer. (accessed May 12, 2023)
•   World Health Organization. Colorectal Cancer Awareness Month 2022 - IARC n.d (accessed May 13, 2023).