Digestive System Cancer, Digestive System Neoplasm
Conditions
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
Interventions
OTHERNutritional psychological interventions and vomit-free management
Nutritional psychological interventions and vomit-free management
Sponsors
Renmin Hospital of Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactYongshun Chen, MD
Outcome results
None listed