Using deep-sea fish oil to prevent esophagitis from radiation therapy
A Randomized Control Study of Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis in Patients With Esophageal Cancer
This study is testing if deep-sea fish oil can help prevent throat irritation in patients getting radiation therapy for esophageal cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Chengdu Medical College Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Chengdu) |
| Trial ID | NCT06392971 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of deep-sea fish oil in preventing acute radiation-induced esophagitis (ARIE) in patients undergoing radiotherapy for esophageal cancer. A total of 120 patients will be randomly assigned to receive either deep-sea fish oil or a placebo, with the treatment administered twice daily. The study will assess the occurrence, severity, and timing of ARIE, as well as changes in nutritional status and potential side effects. The trial is designed as a prospective, single-center, randomized controlled study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed esophageal cancer who are about to undergo radiotherapy.
Not a fit: Patients with prior radiation therapy or severe underlying diseases that contraindicate radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence and severity of esophagitis in patients receiving radiation therapy for esophageal cancer.
How similar studies have performed: While the use of fish oil in this context is novel, similar studies exploring nutritional interventions during cancer treatment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years old, ≤70 years old, gender is not limited; 2. Histological or cytological evidence of esophageal, lung, or breast cancer; 3. ECOG score of 0-2, no swallowing pain or severe dysphagia before radiotherapy; 4. Liver and kidney function, bone marrow function and cardiopulmonary function are not contraindicated by radiotherapy and chemotherapy; 5. PG-SGA score \<9; 6. Not pregnant or breastfeeding; 7. The subject must understand and sign the informed consent 8. Have reading comprehension ability and can complete the questionnaire with medical assistance; 9. Those who voluntarily participate in the study and sign the informed consent letter in person. Exclusion Criteria: 1. Prior radiation therapy; 2. Patients with severe underlying diseases, who cannot tolerate radiotherapy and chemotherapy due to severe liver and kidney insufficiency and poor cardiopulmonary function; 3. Pregnant or lactating female patients; 4. Suffering from severe mental illness and poor compliance; 5. Other cases deemed unsuitable for inclusion by the researchers.
Where this trial is running
Chengdu
- The First Affiliated Hospital of Chengdu Medical College — Chengdu, China (Recruiting)
Study contacts
- Study coordinator: Ke Xu, Doctor
- Email: xuke@cmc.edu.cn
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.