Clinical trial · Interventional
Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis
A Randomized Control Study of Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis in Patients With Esophageal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Purpose：To observe and evaluate the clinical efficacy and safety of deep-sea fish oil in preventing acute radiation-induced esophagitis (ARIE). Methods and Materials：A total of 120 patients with esophageal cancer treated with radiotherapy were randomly assigned (1:1) to treatment or control group. In the treatment group, 1g deep-sea fish oil was oral administrated prophylactically twice a day，the control group was blank control. The clinical efficacy of deep-sea fish oil on prevention of ARIE was evaluated by comparing the differences in the occurrence time, the grade and incidence of ARIE. Additionally, the change in nutritional status was also investigated. Hemanalysis, liver function, kidney function changes， and adverse reactions were compared before and after treatment to evaluate the safety of deep-sea fish oil.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophagitis | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Deep-sea fish oil | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Preventive use of deep-sea fish oil
- interventionNames
- Drug: Deep-sea fish oil
- type
- PLACEBO_COMPARATOR
- label
- Preventive use of placebo
- interventionNames
- Other: Placebo
Primary outcomes (3)
- measure
- The duration from initiation of radiotherapy to the onset of acute radiation esophagitis
- timeFrame
- Approximately 2 months
- measure
- Severity of acute radiation esophagitis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
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