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Trial Title:
Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis
NCT ID:
NCT06392971
Condition:
Radiation Toxicity
Esophagitis
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Esophagitis
Conditions: Keywords:
Fish oil
Acute Radiation-induced Esophagitis
Esophageal Cancer
prevention
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a prospective, single-center, randomized controlled clinical study. 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.
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Deep-sea fish oil
Description:
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.
Arm group label:
Preventive use of deep-sea fish oil
Intervention type:
Other
Intervention name:
Placebo
Description:
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.
Arm group label:
Preventive use of placebo
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Chengdu Medical College
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Ke Xu, Doctor
Start date:
January 15, 2023
Completion date:
April 15, 2026
Lead sponsor:
Agency:
First Affiliated Hospital of Chengdu Medical College
Agency class:
Other
Source:
First Affiliated Hospital of Chengdu Medical College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06392971
