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

January 28, 2024 updated by: Yongshun Chen, Renmin Hospital of Wuhan University
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

316

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin hosptial of Wuhan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
First-line treatment received standard antitumor therapy and nutritional psychological interventions with and without vomit management
Other: Nutritional psychological interventions and vomit-free management
Nutritional psychological interventions and vomit-free management
No Intervention: Control group
First-line treatment receives standard antitumor therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median progression-free survival time
Time Frame: 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.
Approximately 40 months from date of the first participant randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
completion rate
Time Frame: 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
Approximately 40 months from date of the first participant randomization
Disease Control Rate
Time Frame: 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.
Approximately 40 months from date of the first participant randomization
Objective Response Rate
Time Frame: 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.
Approximately 40 months from date of the first participant randomization
Duration of Response
Time Frame: 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).
Approximately 40 months from date of the first participant randomization
Quality of Life(QoL)
Time Frame: 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.
Approximately 40 months from date of the first participant randomization
median Overall Survival
Time Frame: 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.
Approximately 40 months from date of the first participant randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renmin Hospital of Wuhan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WDRY2022-K092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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