Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:During radiotherapy, in addition to standard nutritional support, take 1 g/day of C17:0 functional oil orally daily.
Control group:During radiotherapy, patients will take identical-appearing placebo starch capsules orally each day in addition to standard nutritional support.
Sponsors
Hefei First People's Hospital
Eligibility
Sex/Gender
All
Age
19 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis criteria per the 2021 CSCO Esophageal Cancer Diagnosis and Treatment Guidelines: Patients diagnosed with esophageal squamous cell carcinoma via endoscopy + biopsy pathology; 2. Assessed as inoperable or refusing surgery by hospital multidisciplinary team (MDT) consultation, and undergoing radical intensity-modulated radiotherapy (IMRT); 3. No concurrent metastasis to visceral organs (e.g., lungs, liver, brain) at initial diagnosis of primary esophageal tumor; 4. Karnofsky Performance Status (KPS) score >=70, with an expected survival >6 months; 5. Age =18 years, no gender restrictions; 6. Electrocardiogram (ECG) essentially normal, no unhealed wounds on the body; 7. Renal function: Creatinine (Cr) <=2.0 × upper limit of normal (ULN); 8. Liver function: AST, ALT <= 2.5 times the upper limit of normal (if liver metastasis is confirmed, <= 5 times the upper limit of normal); 9. Voluntary enrollment with good compliance, ability to cooperate with trial observations, and signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Undergoing surgical treatment; 2. Patients with concurrent second primary cancer prior to treatment (excluding cases where no recurrence or metastasis has occurred within 5 years after treatment for the second primary cancer),t; 3. Pregnant or lactating women, or female patients of childbearing potential not using contraception; 4. Presence of severe acute infection that is uncontrolled; or purulent and chronic infections with non-healing wounds; 5. Pre-existing severe cardiac disease, including: congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina, myocardial infarction, severe valvular heart disease, and refractory hypertension; 6. Patients with poorly controlled neurological or psychiatric disorders, poor compliance, inability to cooperate or report treatment responses; uncontrolled primary brain tumors or central nervous system metastases with overt intracranial hypertension or neuropsychiatric symptoms; 7. Patients concurrently enrolled in other clinical trials; 8. Other circumstances where the investigator deems the patient unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-Generated Subjective Global Assessment (PG-SGA) score;Karnofsky Performance Status;BMI ;IL-1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;EORTC QLQ-C30;Serum creatinine;CD4+/CD8+;Radiation esophagitis;Bone marrow suppression;Lymphocyte count;Alanine aminotransferase;Red blood cells;Radiation Pneumonitis;White blood cells;Radiation dermatitis;Serum albumin;Hemoglobin; | — |
Countries
China
Contacts
Public ContactFeng Sun
Hefei First People's Hospital
Outcome results
None listed