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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRenmin Hospital of Wuhan University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75, male or female;

Patients with advanced esophageal cancer, gastric cancer, liver cancer and colorectal cancer and other gastrointestinal tumors diagnosed by pathological histology or cytology;

Expected survival ³ 8 weeks and able to receive long-term follow-up;

Eastern Cooperative Oncology Group(ECOG)-Performance Status(PS) score of 0-2;

Disqualifiers

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;

history of psychiatric illness prior to the diagnosis of the tumor

patients who resist treatment

patients with poorly controlled severe heart disease, liver or kidney insufficiency, severe anemia, multiple lymph node enlargement, leukopenia, etc;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nutritional psychological interventions and vomit-free management

    Other intervention

    Nutritional psychological interventions and vomit-free management

Treatment groups

316 Participants
are divided into 2 treatment groups
Group A: Study groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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