A Phase 2 interventional study of Deep-sea fish oil and Placebo in Radiation Toxicity, Esophagitis and Esophageal Cancer, sponsored by First Affiliated Hospital of Chengdu Medical College. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by First Affiliated Hospital of Chengdu Medical College · Phase 2, Interventional, and Prevention
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.
Radiotherapy is an important treatment for esophageal cancer, and acute radiation-induced esophagitis (ARIE) is the most common complication during radiotherapy. The present study was conducted to investigate the clinical efficacy of deep-sea fish oil in the prevention and treatment of ARIE, and to evaluate the effects of deep-sea fish oil on patients' nutritional status, quality of life, pain management, and the effect on the treatment. This is a prospective, single-center, randomized controlled clinical study. The present study has been registered in the Chinese Clinical Trials Registry (ChiCTR2200056847). The present study intends to continuously enroll 120 patients with esophageal cancer who are to receive radiotherapy, and randomly divide the enrolled patients into two groups. One group receive treatment of deep-sea fish oil and the other group is blank control. The differences of ARIE occurrence, ARIE degree, pain degree, and the changes of the inflammatory index were compared.
328 studies on the registry are indexed under Radiation Injuries; 96 are open to participants now.
This study's planned enrollment of 120 is above the median of 72 across 216 interventional studies indexed under Radiation Injuries.
Browse Radiation Injuries studies →First Affiliated Hospital of Chengdu Medical College is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Deep-sea fish oil
Other: Placebo
Starting from radiotherapy, the whole course of prophylactic oral deep-sea fish oil should be taken at the recommended dosage of 1g po bid according to the instructions (the administration method is to take it with the drug, remove the film on the drug surface, slowly swallow it in a supine position, and make the liquid fully contact with the esophageal mucosa). If no acute radioactive esophagus was assessed during the course of treatment, the patient was administered orally until the end of radiotherapy. If the patient developed radioactive esophagitis during the course of treatment, the relevant outcome measures were recorded and used as the endpoint event of the phase I study. The end point for patients without acute radiation esophagitis was at the completion of radiation therapy.
Take a capsule made of food oil that looks like deep-sea fish oil at a dose of 1g po bid. Treatment is discontinued when patients develop acute radiation esophagitis.
The duration from initiation of radiotherapy to the onset of acute radiation esophagitis
Time frame: Approximately 2 months
Severity of acute radiation esophagitis
Using the Radiation Therapy Oncology Group (RTOG) grading method for radiation esophagitis, patients with acute radiation esophagitis are evaluated daily from the first day onwards. Specifically, level 0: asymptomatic; Grade I: mild dysphagia or pain in swallowing, requiring topical or non-narcotic analgesia; Grade II: moderate dysphagia or swallowing pain, requiring narcotic analgesia; Grade III: severe dysphagia or dysphagia pain, accompanied by dehydration or weight loss greater than 15%, requiring a nasal feeding diet with intravenous fluids or high nutrients; Grade IV: complete obstruction, accompanied by ulceration, perforation, and fistula.
Time frame: Approximately 2 months
Incidence of severe acute radiation esophagitis
Time frame: Approximately 2 months
Pain degree
For patients with acute radiation esophagitis in the two groups, the Numerical Rating Scale (NRS) pain scoring method was used to evaluate the pain degree daily from the first day of acute radiation esophagitis, which was usually divided into the following criteria: 0 score: no pain 2; Scores 1-3: mild pain; 4-6 points: moderate pain; Score 7-10: Severe pain. The NRS score is based on a 10-point scale of pain, and the patient makes a numerical score to let the doctor know the level and level of pain.
Time frame: Approximately 2 months
The concentration of plasma C-reactive protein
The concentrations of plasma C-reactive protein were measured at three-time points at the beginning of radiotherapy, completion of 10 fractionated radiotherapy, and completion of 20 fractionated radiotherapy.
Time frame: Approximately 2 months
The concentration of plasma IL-6
The concentrations of plasma IL-6 were measured at the beginning of radiotherapy, completion of 10 fractionated radiotherapy, and completion of 20 fractionated radiotherapy.
Time frame: Approximately 2 months
Plan to share: No
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First Affiliated Hospital of Chengdu Medical College