Nutritional and psychological support for patients with advanced gastrointestinal tumors
Nutritional Psychological Intervention and Vomit-free Management on Survival and Quality of Life in Advanced Gastrointestinal Tumors
This study is testing if adding nutritional and psychological support to standard cancer treatment can help people with advanced gastrointestinal tumors live longer and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 316 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Renmin Hospital of Wuhan University Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06223230 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of nutritional psychological interventions and vomit-free management on the survival and quality of life of patients with advanced gastrointestinal tumors, including esophageal, gastric, liver, pancreatic, and colorectal cancers. Participants will be divided into two groups: one receiving standard oncology treatment along with the interventions, and the other receiving only standard treatment. The aim is to determine if the additional support improves outcomes compared to standard care alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with advanced gastrointestinal tumors who are able to undergo standard oncology treatment.
Not a fit: Patients with other malignant tumors diagnosed within the previous 5 years or a history of psychiatric illness prior to their cancer diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance survival rates and quality of life for patients with advanced gastrointestinal cancers.
How similar studies have performed: While similar approaches have been explored, this specific combination of nutritional and psychological interventions in advanced gastrointestinal tumors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Wuhan, Hubei
- Renmin hosptial of Wuhan University — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Yongshun Chen, MD
- Email: yongshun2007@163.com
- Phone: +86 15327122084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.