untitled h1
untitled h2

Official Title of the study:
Impact of Nutritional Status on Clinical Outcomes in Cancer Patients Receiving Chemoradiotherapy in Shaanxi Province NCT ID:
not yet assigned Date:
12/23/2023
untitled h1
1. project overview

| Cooperat                                                                                                                                                                                                                                                                                                                                                                                                          | Name of unit                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                                                           |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| ion Unit  Informati                                                                                                                                                                                                                                                                                                                                                                                               | 20 hospitals in Shaanxi                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                           |
| on                                                                                                                                                                                                                                                                                                                                                                                                                | Study on the correlation between nutritional status and                                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                           |
| Project                                                                                                                                                                                                                                                                                                                                                                                                           | Project name                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | clinical outcomes of radiotherapy patients with tumors in |
| Basic                                                                                                                                                                                                                                                                                                                                                                                                             | Shaanxi Province                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |                                                           |
| Informati                                                                                                                                                                                                                                                                                                                                                                                                         | Estimated number of                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | 3 years                                                   |
| years of research                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                           |
| on                                                                                                                                                                                                                                                                                                                                                                                                                | Request for funding                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | 566,000                                                   |
| Content and significance of the study                                                                                                                                                                                                                                                                                                                                                                             |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                           |
| Cancer is the second leading cause of death worldwide, and malnutrition is an                                                                                                                                                                                                                                                                                                                                     |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                           |
| important factor in the development of tumors and the most common complication  in patients undergoing radiotherapy for tumors. It severely diminishes the  effectiveness of antitumor therapy, increases complications, increases mortality,  decreases survival, prolongs hospitalization and increases costs. The impact of  nutritional status continues throughout tumor progression and is one of the major |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                           |
| Overvie                                                                                                                                                                                                                                                                                                                                                                                                           | factors in adverse clinical outcomes in tumors. Although nutrition is crucial for                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                           |
| w                                                                                                                                                                                                                                                                                                                                                                                                                 | patients with malignant tumors, the reported prevalence of malnutrition in oncology  patients is very variable, with 30% to 80% being reported, and the population  distribution of malnutrition in oncology patients is characterized by a lack of large  sample surveys, and malnutrition is still an issue that needs to continue to be studied  in depth. Radiotherapy and chemotherapy are the main treatment methods for tumor  patients at present. However, radiotherapy and chemotherapy have certain harm to |                                                           |  
| patients, which can cause nausea and vomiting, loss of appetite, abdominal  distension and diarrhea, reduction of saliva, sore throat, difficulty in swallowing,  abnormal metabolism of nutrients, and malodorous fluid, thus affecting patients'  eating and resulting in malnutrition and weight loss. This has serious adverse effects  on the physical and psychological conditions and nutritional status of cancer  patients. There is no single cause for the decline in nutritional status of radiotherapy  patients; there are many factors that may cause or directly contribute to the decline  in nutritional status. Risk factors include the type and location of the tumor, length  of hospitalization, immunodeficiency, and possibly the treatment process itself. Therefore, this study intends to recruit oncology radiotherapy patients from  multiple centers and establish a large sample cohort to explore the factors  influencing and changes and trends in nutritional status of oncology patients at  different stages by describing their nutritional mounts as well as the trajectory of  changes at different stages of radiotherapy. The study will also investigate the  prevalence of malnutrition during hospitalization and post-discharge clinical followup, and explore whether nutritional status, physical condition and quality of life at  admission/after radiotherapy predict overall survival in common cancer patients;  study the relationship between nutritional status and different demographic  characteristics of cancer patients; assess whether malnourished cancer patients  receive standardized nutritional therapy during radiotherapy and analyze its  benefits; and develop a survival prediction model based on nutritional indicators of  cancer patients. The results of this study will establish a large-scale refined  information base of dietary and nutritional data of cancer patients in our province  while helping the whole medical nutritional management of cancer patients.         |                                              |
|---------|----------------------------------------------|
| Keyword | Tumor; Nutrition; Radiotherapy; Chemotherapy |
| s       |                                              |
untitled h1
2. information on research projects

To investigate the nutritional status and changing trends of tumor radiotherapy patients at different stages in our province.
untitled h1
2.2 content of the study

In this study, we intend to recruit patients with tumor radiotherapy to establish a cohort in 20 hospitals in Shaanxi Province, and to observe the long-term effects of clinical oncology treatment measures on the basis of clinically relevant treatments. The follow-up arrangements were within 1 month after starting treatment, 3 months, 6 months, 12 months, and 24 months after treatment. Nutritional status and disease condition of the patients were the primary endpoints of the study, and laboratory test data, anthropometric measurements, and quality of life of the patients were the secondary endpoints of the study.  
Random sampling method was used to draw survey respondents: cooperative hospitals in the province were selected as the survey hospitals; the indicated number of samples were drawn within each hospital according to the volume-proportional probability sampling method (PPS). Considering the impact of patient demographic composition and non-response rate, if the number of cases of tumor inpatients over 18 years of age in the sampled hospitals could not satisfy the minimum sample size requirement, tumor inpatients in other hospitals of the same level were combined according to the principle of proximity and proximity. The principle of selecting tumor types in this study was common malignant tumors derived from the top 10 common malignant tumors in China, the top 10 malignant tumors in Chinese males, the top 10 malignant tumors in Chinese females, and the top 10 malignant tumors in the world.16 The common malignant tumors investigated were: lung cancer, gastric cancer, hepatocellular carcinoma, breast cancer, esophageal cancer, cervical cancer, leukemia, bladder cancer, pancreatic cancer, prostate cancer, ovarian cancer, and nasopharyngeal cancer, colorectal cancer, endometrial cancer, malignant lymphoma, and brain malignancy.
untitled h1
[sample size]

The first phase goal of this study is proposed to recruit 1,000 target people to establish a cohort in 2022, with a cumulative cohort of 3,000 by the end of 2023, a cumulative cohort of 6,000 by the end of 2024, and a projected cumulative cohort of 10,000 by the end of 2025. That is, 50 people will be recruited in each sub-center (20 sub-centers in total) in the first phase respectively, and 500 people will be recruited in each sub-center cumulatively by the end of 2025.
untitled h1
[inclusion criteria]

a. Adults over the age of 18; b. Pathology confirmed the diagnosis of a malignant tumor; c. Will be treated with radiation and/or chemotherapy; d. Mental clarity, no communication difficulties; e. Willingness to be followed up, non-endangered; f. Patients with multiple admissions may be investigated several times and recorded as several  
cases.
untitled h1
[exclusion criteria]

a. Patients with malignant tumors without pathologic diagnosis;  
b. AIDS;
c. Mental or cognitive disorders; d. Organ transplant recipients; e. Those with a survival period shorter than 12 months; f. Pregnant patients; g. Those who are also involved in other clinical intervention studies. [Main ending]
Nutritional status and disease of the patient.
untitled h1
[secondary ending]

Patients' laboratory test data, anthropometric indicators, and quality of life status.  
[Specifics]
untitled h1
1 basic patient information a.

⚫ Basic personal information includes: name, sex, date of birth, marriage, occupation, education level, history of previous illnesses, and use of drugs and health care products.  
⚫ Personal medical history, defined as medical history within the previous year, based on the admission diagnosis and medical records in the hospitalization log, this section may be multiple choice.  
⚫ Family history of tumors.  
⚫ Personal lifestyle habits, meaning that all study participants were surveyed for smoking, alcohol and tea consumption.  
⚫ Dietary survey A 3-day, 24-hour retrospective survey was used, including diets on 2 weekdays and 1 Sunday. The investigator instructed the study participants on how to keep a detailed record of all food types and portion sizes consumed during the survey period. The researcher was required to verify what they had filled in when the questionnaire was returned.
untitled h1
b. disease conditions

⚫ Pathologic staging, in this case tumor staging, refers specifically to the staging at the time of initial (first) diagnosis , not at the time of investigation.  
⚫ If genetic testing was performed, molecular pathology markers were required.  
⚫ Date of first diagnosis means the date of diagnosis of the pathology report.  
⚫ Major tumor diagnosis, as documented in the medical record.  
⚫ Holoma status refers to the immediate situation that arises at the time of the survey.  
⚫ Primary treatment the patient has received, including primary treatment since
diagnosis to the time of investigation.  
⚫ Previous nutritional support received in the week prior to the survey. ⚫ The patient's current functional status.
untitled h1
c. card scoring

⚫ Health status self-scoring criteria (KPS scoring criteria), the score card's inquiry focus on the ability to carry out normal activities, physical discomfort, life can take care of themselves, and the level of classification of these three inquiry focus.
untitled h1
2 clinical trial a. laboratory

⚫ Includes total protein, albumin, prealbumin, transferrin, C-reactive protein, glucose, AST, ALT, interleukin-1, TNF-alpha, creatinine, urea nitrogen, total bilirubin, direct bilirubin, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, interleukin-6, hemoglobin, leukocytes, neutrophil count, lymphocyte count, red blood cells , platelets.  
⚫ The values for each test are for the most recent test available at the time of the survey. If the hospital does not conduct the relevant test, fill in the slash. However, total protein, albumin, prealbumin, C-reactive protein and interleukin-6 are compulsory.
untitled h1
b. body composition analysis

⚫ Units with multi-frequency body composition instruments are required to measure body composition and are not required to have all units participate.
untitled h1
c. anthropometry

⚫ Height, weight, waist-hip circumference and blood pressure were measured according to standardized methods, and body mass index and waist-hip ratio were calculated.  
⚫ Height, weight and waist circumference measurements require an empty stomach, free shoes and a single garment. Measurements should be taken in person, avoiding asking the patient and filling in directly.  
⚫ Height is accurate to 0.5cm, weight is accurate to 0.2kg, waist circumference is accurate to 0.1cm; BMI is retained to 1 decimal place. This value is inaccurate if there is abdominal fluid, generalized edema, huge tumors, etc., and should be specified.  
⚫ Time required to walk 6 meters at normal speed, accurate to 1 second, step speed online system automatically calculates, retain 1 decimal place.  
⚫ Waist circumference measurement: horizontal circumference through the center of the umbilicus, or the circumference of the midpoint line between the lowest point of the rib and the two horizontal lines of the superior margin of the iliac crest.  
⚫ The circumference of the midpoint of the upper arm and the thickness of the skinfold of the triceps muscle of the examined hand should be non-lipped (usually left-handed).  
⚫ Measurement of triceps skinfold thickness: the examinee's arms were naturally draped, with the palms facing the lateral thighs, and the examiner detected the lateral skinfold thickness at the midpoint of the upper arm from behind, taking the average of 3 measurements to an accuracy of 0.1 mm.  
⚫ Measurement of the midpoint circumference of the upper arm: the subject's arms were naturally draped, with the palms facing the side of the thighs, and the circumference of the midpoint of the upper arm was measured to an accuracy of 0.1 cm.  
⚫ Muscle circumference at midpoint of upper arm (MAMC, cm) = MAC (cm) -
0.314 x TSF (mm).
⚫ Hand Grip Strength: Measurement of sharp and non-sharp (or non-injured) hand grip strength, averaged over 3 occasions and accurate to 0.1kg.  
⚫ Measurement of the maximum circumference of the calf: the patient was lying on his back, the left leg was selected, and the right leg was selected when the condition was not allowed, the maximum circumference of the calf was measured, and the maximum value was taken for three consecutive times.
untitled h1
3 pg-sga a. patient self-assessment

⚫ It is divided into four sections: weight, feeding, symptoms, activity and physical function.
untitled h1
b. medical staff assessment form

⚫ The Disease Score Sheet **(B Score)** is a cumulative score. If a patient has a disease that is not listed on the worksheet, no points will be awarded.  
⚫ Stress **(C score)**, the patient's temperature was the actual temperature measured at the time of assessment. Fever was defined here as an elevated temperature at the moment of this investigation; if the temperature was elevated at the time of the investigation, the temperature and hormone use in the 3 days prior to this moment needed to be known. If the temperature was not elevated at the moment of investigation, it was recorded as no fever. The duration of fever is the time that the current fever has lasted Hormone use is due to the use of hormones for fever, if hormones are used for several days in a row, take the largest one-day dose. Hormone use for other reasons, such as connective tissue disease, was not assessed.  
⚫ Physical examination **(D score)**, including fat stores, muscle condition, and
edema.
untitled h1
c. comprehensive evaluations

⚫ Qualitative evaluation, this study does not do qualitative evaluation.  
⚫ For quantitative evaluation, the four total scores are added together =
A+B+C+D.
untitled h1
4 nutritional risk screening -

⚫ Total nutritional risk score was obtained by disease score, nutrition score, and age score.
untitled h1
5 quality of life survey

⚫ The quality of life form for oncology patients can be completed as per the actual questioning.  
⚫ All refer to more common manifestations, and once-in-a-while occurrences are not available as options .
untitled h1
6 nutritional support during hospitalization

⚫ Patients are asked to provide information about their nutritional support during hospitalization including the mode of parenteral or enteral nutrition, preparation and supplemental dose.
untitled h1
7 recent clinical outcome indicators

⚫ Outcome within 30 days of this admission (death, no follow-up required/survival, follow-up required).  
⚫ Duration of this hospitalization.  
⚫ The cost of this hospitalization.  
⚫ Weight 30 days after this admission.
untitled h1
8 investigator self-check 9 record

⚫ Includes date of planned follow-up, time of contact (not contacted three times is considered lost), visit status, survival status, cause of death, physical status (KPS score, weight, BMI, etc.) with quality of life score.
untitled h1
2.3 research progress

① 2022.05-2022.07 Literature study, research plan involved, project creation, form setup.  
② 2022.07-2022.08 Communicate with partner hospitals for program testing.  
③ 2022.07-2026.12 Field data collection, data quality control and management, and follow-up analysis and research outputs for the first target.
untitled h1
2.4 quality control

① Evaluation time Nutritional assessment was performed at the time of their visit for outpatient applicants and within 48h of their admission for inpatient applicants. Home oncology patients received nutritional assessment at the outpatient clinic once a month, and inpatient oncology patients had nutritional assessment again at the end of a treatment course or every 2 weeks.  
② Implementers All staff members of each center receive relevant training in a uniform manner.  
The training includes procedures, methods, content, criteria, outcome determination and management of the assessment. Implementers should have the experience of completing at least 10 patient assessments under the guidance of others (those with assessment experience) before they can conduct nutritional assessments independently.  
③ Assessment and communication of interventions The subject should be briefed about the purpose and content of the assessment and its necessity before assessment and intervention. Informed consent should be obtained from the patient and approval from the hospital ethics committee is required.
untitled h1
2.5 ethical issues

Subjects: Project staff ensured that the subjects had a correct and comprehensive understanding of the purpose, significance and implementation process of the project.  
Informed Consent: All eligible subjects gave informed consent. All information collected from study participants is kept confidential and is guaranteed to be used only for the purposes of this project and will not be disclosed to anyone without the consent of the study participants.  
Institutional review: The project application was submitted to the Ethics Committee of Xi'an Jiaotong University School of Medicine for review.