Clinical Study on Nutrition Intervention in Patients With Esophageal and Gastric Cancer Treated With Chemotherapy
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ClinicalTrials.gov Identifier: NCT06022770 |
Recruitment Status :
Not yet recruiting
First Posted : September 5, 2023
Last Update Posted : September 5, 2023
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Sponsor:
Hunan Cancer Hospital
Collaborator:
The Third Xiangya Hospital of Central South University
Information provided by (Responsible Party):
Hunan Cancer Hospital
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Brief Summary:
Patients with esophageal cancer and gastric cancer undergoing chemotherapy were selected as research objects to conduct nutritional risk screening, malnutrition assessment and quality of life assessment. They were randomized into the nutrition counseling group (NC) and the nutrition support therapy group (NST). To evaluate the nutrition and life quality of patients with esophageal cancer and gastric cancer before and after chemotherapy, and to study the effects of nutritional support therapy on nutrition and life quality.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nutrition Aspect of Cancer | Dietary Supplement: Nutritional counseling,Enteral Nutrition | Not Applicable |
In view of the high incidence of malnutrition in esophageal cancer and gastric cancer and chemotherapy may further aggravate malnutrition and reduce quality of life. According to the inclusion criteria, 280 patients with esophageal cancer and gastric cancer undergoing chemotherapy were selected as research objects to conduct nutritional risk screening, malnutrition assessment and quality of life assessment. They were randomized into the nutrition counseling group (NC) and the nutrition support therapy group (NST). To evaluate the nutrition and life quality of patients with esophageal cancer and gastric cancer before and after chemotherapy, and to study the effects of nutritional support therapy on nutrition and life quality; On this basis, a nutrition and life quality management system for patients with tubular upper digestive tract chemotherapy tumors was constructed, and the system was objectively evaluated from the clinical point of view, so as to provide a feasible scheme for improving the nutrition and life quality of patients with tubular upper digestive tract chemotherapy tumors.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Supportive Care |
Official Title: | Clinical Study on Nutrition Intervention to Improve Nutrition and Quality of Life in Patients With Esophageal and Gastric Cancer Treated With Chemotherapy |
Estimated Study Start Date : | August 30, 2023 |
Estimated Primary Completion Date : | December 30, 2024 |
Estimated Study Completion Date : | December 30, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Stomach Cancer
Arm | Intervention/treatment |
---|---|
No Intervention: Nutritional Counseling | |
Experimental: Nutrition Support Therapy |
Dietary Supplement: Nutritional counseling,Enteral Nutrition
patients with esophageal cancer and gastric cancer undergoing chemotherapy were selected as the study objects for nutritional risk screening, malnutrition assessment and quality of life assessment. Randomly enter the nutrition consultation group (NC) and nutrition support treatment group (NST) |
Primary Outcome Measures :
- Nutritional risk screening(NRS) 2002 scale [ Time Frame: Nutritional risk screening(NRS) 2002 scale during day 1 and day 42 ]Nutritional risk screening(NRS) 2002 scale of patients with esophageal and gastric cancer before and after chemotherapy. The score includes 0,1,2,3,4,5,6 and 7.
Secondary Outcome Measures :
- rates of malnutrition of patients [ Time Frame: rates of malnutrition of patients during day 1 and day 42 ]Rates of malnutrition of patients with esophageal and gastric cancer before and after chemotherapy. The result is shown as "percent".
- quality of life of patients with esophageal and gastric cancer before and after chemotherapy [ Time Frame: rates of quality of life of patients during day 1 and day 42 ]quality of life of patients with esophageal and gastric cancer before and after chemotherapy. The scale include EQ-5D (score of 0-1)
- quality of life of patients with esophageal and gastric cancer before and after chemotherapy [ Time Frame: rates of quality of life of patients during day 1 and day 42 ]quality of life of patients with esophageal and gastric cancer before and after chemotherapy. The scale include EQ-5D VAS (score of 1-100)
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Esophageal or gastric cancer confirmed by histology or cytology;
- Age 18-75 years old, gender unlimited;
- Blood routine: hemoglobin ≥90g/L, absolute neutrophil count (ANC) ≥1.5×109/L, platelets ≥100×109/L; (2) Liver and kidney function: alanine transaminase(ALT), glutamic-oxalacetic transaminease(AST)≤2.5 times the normal upper limit (with liver metastasis ≤5 times the normal upper limit); ALP≤2.5 times the normal upper limit (≤5 times the normal upper limit for patients with liver or bone metastasis); Serum total bilirubin (TBIL) was less than 1.5 times the normal upper limit. Serum creatinine (SCr) < 1.5 times the upper limit of normal; ③ Blood biochemistry: Serum albumin (ALB) ≥30g/L;
- Predicted survival of more than 3 months; It is planned to continue chemotherapy for >3 cycles in the hospital or outpatient department
- All patients participated in this study voluntarily and signed informed consent.
Exclusion Criteria:
- Other tumors, including pancreatic cancer, liver cancer and other solid digestive tract tumors, colon cancer, rectal cancer and other tubular lower digestive tract tumors;
- Have serious heart, lung and brain diseases; Complicated with chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency, etc.
- Fever associated with infection; Have difficult-to-control diabetes or other metabolic diseases;
- Patients with unstable vital signs and multiple organ failure;
- The patient has poor cognitive ability and is unable to answer questions or fill out questionnaires.
- The investigator believes that the subjects have a history of other serious systemic diseases or are not suitable for participating in this clinical study for other reasons
No Contacts or Locations Provided
Responsible Party: | Hunan Cancer Hospital |
ClinicalTrials.gov Identifier: | NCT06022770 |
Other Study ID Numbers: |
HunanCH-50 |
First Posted: | September 5, 2023 Key Record Dates |
Last Update Posted: | September 5, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |