Nutrition intervention for patients with advanced cancer
Early Nutrition Intervention for M1 Stage Cancer Patients：a Single-center,Open,Randomized Controlled Trial
This study is testing whether adding nutrition support from dietitians can help patients with advanced cancer feel better and manage symptoms like appetite and weight loss while they prepare for chemotherapy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06332664 on ClinicalTrials.gov |
What this trial studies
This study aims to integrate clinical nutritionists into the oncology treatment team to provide proactive nutritional interventions for patients with M1 stage advanced cancer. By focusing on patients who are untreated and require chemotherapy, the study evaluates the impact of early nutritional support on managing symptoms like appetite loss and weight loss. It is a single-center, open-label, randomized parallel-group prospective study conducted at West China Hospital in Chengdu, Sichuan. The goal is to improve the overall nutritional status and quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 with untreated M1 advanced cancer who are in good cognitive health and have a life expectancy of at least three months.
Not a fit: Patients with severe digestive or metabolic diseases, neurological disorders, or those in a cachectic state may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the nutritional status and overall well-being of patients undergoing treatment for advanced cancer.
How similar studies have performed: While the integration of nutritionists into oncology care is gaining attention, this specific proactive approach for M1 stage cancer patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The patients should be at the range of 18-80 years old, Eastern Cooperative Oncology Group (ECOG) 0-1. 2. The patients should be diagnosed, untreated M1 advanced cancer patients requiring chemotherapy; 3. The patients should have good cognitive and reading abilities to complete questionnaires; 4. The patients should have ≥3 months expected survival period Exclusion Criteria: 1. Patients with neurological or psychiatric disorders affecting cognitive function, including central nervous system metastases from tumors; 2. Patients with severe diseases affecting digestion, metabolism, or food intake; 3. Presence of contraindications to chemotherapy; 4. Patients in a cachectic state or refractory cachexia; 5. Patients requiring primary tumor radiation therapy. 6. Patients with PG-SGA score ≥9 points
Where this trial is running
Chengdu, Sichuan
- West China Hospital, Sichuan Universit — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: XingChen Peng, Ph.D — West China Hospital
- Study coordinator: XingChen Peng, Ph.D
- Email: pxx2014@163.com
- Phone: +8618980606753
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.