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A randomized controlled study of oral immunonutritional therapy for improving tolerance of chemotherapy in patients with advanced lung cancer

A randomized controlled study of oral immunonutritional therapy for improving tolerance of chemotherapy in patients with advanced lung cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078741
Enrollment
Unknown
Registered
2023-12-18
Start date
2023-12-22
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced lung cancer

Interventions

Immunonutrition support:In this study, the experimental group will receive 2-3 bottles of oral immunonutrient supplements per day for a total of 10 days, starting after chemotherapy in each treatment
Control group:standard nutritional education and intervention

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Before any study-specific procedures, sampling, or analysis, the subject must sign a written informed consent form in accordance with current guidelines and indicate the date. 2. At the time of signing the informed consent form (ICF), the subject must be =18 years old. 3. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4. Histologically or cytologically confirmed malignancy of pulmonary origin. 5. Histologically or cytologically confirmed metastatic or locally advanced NSCLC, not suitable for curative treatment, and planned to receive chemotherapy-based treatment. 6. Expected survival of more than 6 months.

Exclusion criteria

Exclusion criteria: Subjects meeting any of the following criteria will be excluded: 1. Currently suffering from a hematologic malignancy. 2. Tumors of other pathological types that are histologically different from the tumor type in this study, except for carcinoma in situ of the cervix, ductal carcinoma in situ, prostate intraepithelial neoplasia, superficial non-invasive bladder cancer, and cured stage I skin cancer (excluding melanoma). 3. Known allergy to oral immunonutrients, oral nutrients, and their components. 4. Difficulty in oral feeding. 5. Coexisting autoimmune diseases.

Design outcomes

Primary

MeasureTime frame
Quality of life (QLQ-C30) assessed by researchers after 2 cycles of treatment;

Secondary

MeasureTime frame
Objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and treatment-related adverse events (TRAEs) as assessed by researchers;

Countries

China

Contacts

Public ContactJiuwei Cui

The First Hospital of Jilin University

cuijw@jlu.edu.cn+86 158 4307 3215

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 29, 2026