Nutritional Psychological Intervention and Vomit-free Management on Survival and Quality of Life in Advanced Gastrointestinal Tumors

Not Applicable

Recruiting

• Conditions: Digestive System Cancer; Digestive System Neoplasm
• Interventions: Other: Nutritional psychological interventions and vomit-free management

• Registration Number: NCT06223230
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-25
• Last Update Submitted: 2024-01-28
• Last Update Posted: 2024-01-30
• Primary Completion: 2025-09-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

1. Age 18-75, male or female;
2. Patients with advanced esophageal cancer, gastric cancer, liver cancer and colorectal cancer and other gastrointestinal tumors diagnosed by pathological histology or cytology;
3. Expected survival ³ 8 weeks and able to receive long-term follow-up;
4. Eastern Cooperative Oncology Group(ECOG)-Performance Status(PS) score of 0-2;
5. First-line treatment receiving standard oncology treatment and nutritional psychological intervention and vomit-free management group (study group); first-line treatment receiving only standard oncology treatment group (control group);
6. Voluntarily signing an informed consent form.

Exclusion Criteria

1. Other malignant tumors diagnosed within the previous 5 years, except for effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or effectively resected in situ cervical cancer or breast cancer;
2. history of psychiatric illness prior to the diagnosis of the tumor
3. patients who resist treatment
4. patients with poorly controlled severe heart disease, liver or kidney insufficiency, severe anemia, multiple lymph node enlargement, leukopenia, etc;
5. patients who are pregnant or have a pregnancy plan;
6. patients who, in the judgment of the investigator, are not suitable for inclusion in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Nutritional psychological interventions and vomit-free management	First-line treatment received standard antitumor therapy and nutritional psychological interventions with and without vomit management

Primary Outcome Measures

Name	Time	Method
Median progression-free survival time	Approximately 40 months from date of the first participant randomization	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.

Secondary Outcome Measures

Name	Time	Method
completion rate	Approximately 40 months from date of the first participant randomization	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
median Overall Survival	Approximately 40 months from date of the first participant randomization	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.
Quality of Life(QoL)	Approximately 40 months from date of the first participant randomization	Survival quality was compared by the Karnofsky Performance Status (KPS)score, a Karnofsky functional status rating scale.
Duration of Response	Approximately 40 months from date of the first participant randomization	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).
Disease Control Rate	Approximately 40 months from date of the first participant randomization	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.
Objective Response Rate	Approximately 40 months from date of the first participant randomization	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.

Trial Locations

Locations (1)

Renmin hosptial of Wuhan University; 🇨🇳 Wuhan, Hubei, China