An interventional study of Nutritional psychological interventions and vomit-free management in Digestive System Cancer and Digestive System Neoplasm, sponsored by Renmin Hospital of Wuhan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Renmin Hospital of Wuhan University · Not applicable, Interventional, and Supportive care
Aims to observe and evaluate the impact of survival and quality of life of patients with gastrointestinal tumors such as advanced esophageal, gastric, liver, pancreatic, and colorectal cancers through nutritional-psychological interventions versus no-vomit management compared to standard antitumor therapy alone
311 studies on the registry are indexed under Digestive System Neoplasms; 83 are open to participants now.
This study's planned enrollment of 316 is above the median of 50 across 233 interventional studies indexed under Digestive System Neoplasms.
Browse Digestive System Neoplasms studies →Renmin Hospital of Wuhan University is the lead sponsor of 83 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
First-line treatment received standard antitumor therapy and nutritional psychological interventions with and without vomit management
Other: Nutritional psychological interventions and vomit-free management
First-line treatment receives standard antitumor therapy
Nutritional psychological interventions and vomit-free management
Median progression-free survival time
Progression-free survival is defined as the period from the date of treatment to the date of the first occurrence of disease progression or death from any cause, whichever occurs first. Median progression-free survival is the time to progression-free survival that corresponds to when the cumulative progression-free survival rate is 0.5, indicating that 50% of individuals will live through this time without disease progression.
Time frame: Approximately 40 months from date of the first participant randomization
completion rate
The treatment completion rate is defined as the ratio of the number of patients actually completing the established intensity or number of cycles of treatment for subjects enrolled in the study to the total number of patients scheduled to complete the established intensity or number of cycles of treatment during the same period, in accordance with the conventional antineoplastic treatment schedule
Time frame: Approximately 40 months from date of the first participant randomization
Quality of Life(QoL)
Survival quality was compared by the Karnofsky Performance Status (KPS)score, a Karnofsky functional status rating scale.
Time frame: Approximately 40 months from date of the first participant randomization
median Overall Survival
Overall survival(OS) is defined as the period from the date of treatment to the date of death from any cause. The OS of patients who were alive at the last follow-up visit was counted as data censored at the time of the last follow-up visit. For patients who were lost to follow-up, their OS was data censored at the time of last confirmed survival prior to loss to follow-up. Median overall survival, which is the survival time corresponding to when the cumulative survival rate is 0.5, indicates that 50% of individuals will live beyond this time.
Time frame: Approximately 40 months from date of the first participant randomization
Disease Control Rate
Refers to the proportion of patients whose tumors shrink or are stable and remain so for a certain period of time, and includes cases of CR, PR and SD. Subjects had to be accompanied by a measurable tumor lesion at baseline, and the efficacy rating criteria were classified as complete remission (CR), partial remission (PR), stable disease (SD), and disease progression (PD) according to RECIST v1.1.
Time frame: Approximately 40 months from date of the first participant randomization
Objective Response Rate
Refers to the proportion of patients whose tumors have shrunk to a certain level and remained there for a certain period of time, and includes both CR and PR cases.
Time frame: Approximately 40 months from date of the first participant randomization
Duration of Response
Refers to the time from the first time the tumor was assessed as CR or PR (whichever was measured first) to the time of the first true recording of PD (using the smallest measurement recorded in the trial as a reference for disease progression).
Time frame: Approximately 40 months from date of the first participant randomization
Plan to share: No
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Renmin Hospital of Wuhan University