Radiation ToxicityPhase 2NCT06392971
Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis
A Phase 2 study testing Deep-sea fish oil in people with Radiation Toxicity and Esophagitis, run by First Affiliated Hospital of Chengdu Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiation Toxicity, Esophagitis, Esophageal Cancer
- What is being tested?
- Deep-sea fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2023to 15 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, ≤70 years old, gender is not limited;
- Histological or cytological evidence of esophageal, lung, or breast cancer;
- ECOG score of 0-2, no swallowing pain or severe dysphagia before radiotherapy;
- Liver and kidney function, bone marrow function and cardiopulmonary function are not contraindicated by radiotherapy and chemotherapy;
- PG-SGA score <9;
- Not pregnant or breastfeeding;
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- The subject must understand and sign the informed consent
- Have reading comprehension ability and can complete the questionnaire with medical assistance;
- Those who voluntarily participate in the study and sign the informed consent letter in person.
Who cannot join
- Prior radiation therapy;
- Patients with severe underlying diseases, who cannot tolerate radiotherapy and chemotherapy due to severe liver and kidney insufficiency and poor cardiopulmonary function;
- Pregnant or lactating female patients;
- Suffering from severe mental illness and poor compliance;
- Other cases deemed unsuitable for inclusion by the researchers.
Trial locations and contacts
1 site in 1 country.
Ke Xu, Doctor contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chengdu Medical College
Chengdu
Ke Xu, Doctor
About this study
Official title: A Randomized Control Study of Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis in Patients With Esophageal Cancer
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.
Read the 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.
- Conditions
- Radiation Toxicity, Esophagitis, Esophageal Cancer
- Being tested
- Deep-sea fish oil, Placebo
- Keywords
- Fish oil, Acute Radiation-induced Esophagitis, Esophageal Cancer, prevention
- Medical subject headings
- Radiation Injuries, Esophagitis, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep-sea fish oilDrug
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Preventive use of deep-sea fish oil | Experimental | Not described Receives: Drug: Deep-sea fish oil |
| Preventive use of placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration from initiation of radiotherapy to the onset of acute radiation esophagitis
Measured: 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.
Measured: Approximately 2 months
Incidence of severe acute radiation esophagitis
Measured: Approximately 2 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start15 Jan 2023
- Primary completion15 Mar 2024
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392971
- Sponsor's protocol ID
- 23LCYJ049
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Study of Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis in Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT06392971
- Acronym / sponsor ID
- 23LCYJ049
- Conditions
- Radiation Toxicity, Esophagitis, Esophageal Cancer
- Keywords
- Fish oil, Acute Radiation-induced Esophagitis, Esophageal Cancer, prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical CollegeUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Preventive use of deep-sea fish oil | Experimental | Drug: Deep-sea fish oil |
| Preventive use of placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years old, ≤70 years old, gender is not limited;
- Histological or cytological evidence of esophageal, lung, or breast cancer;
- ECOG score of 0-2, no swallowing pain or severe dysphagia before radiotherapy;
- Liver and kidney function, bone marrow function and cardiopulmonary function are not contraindicated by radiotherapy and chemotherapy;
- PG-SGA score <9;
Key exclusion criteria (5 listed)
- Prior radiation therapy;
- Patients with severe underlying diseases, who cannot tolerate radiotherapy and chemotherapy due to severe liver and kidney insufficiency and poor cardiopulmonary function;
- Pregnant or lactating female patients;
- Suffering from severe mental illness and poor compliance;
- Other cases deemed unsuitable for inclusion by the researchers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep-sea fish oilStarting 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. | Drug | Preventive use of deep-sea fish oil |
| PlaceboTake 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. | Other | Preventive use of placebo |
Primary outcome
The duration from initiation of radiotherapy to the onset of acute radiation esophagitis
Time frame: Approximately 2 months
Severity of acute radiation esophagitis
Time frame: Approximately 2 months
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.
Incidence of severe acute radiation esophagitis
Time frame: Approximately 2 months
3 secondary outcomes
Pain degree
Time frame: Approximately 2 months
The concentration of plasma C-reactive protein
Time frame: Approximately 2 months
The concentration of plasma IL-6
Time frame: Approximately 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ke Xu, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deep-sea fish oil in people with Radiation Toxicity and Esophagitis, run by First Affiliated Hospital of Chengdu Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke Xu, Doctor (xuke@cmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration from initiation of radiotherapy to the onset of acute radiation esophagitis (time frame: Approximately 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.