To evaluate the efficacy and safety of a Spirulina-derived product in preventing and treating radiation-induced esophagitis in esophageal cancer patients undergoing intensity-modulated radiotherapy (IMRT).
The goal of this clinical trial is to evaluate the efficacy and safety of a spirulina-derived product in reducing the incidence, duration, and severity of radiation-induced esophagitis in esophageal cancer patients. The study primarily aims to address two questions: (1) whether the spirulina-derived product can effectively prevent and mitigate radiation-induced esophageal injury, and (2) whether its use is associated with adverse events in patients undergoing intensity-modulated radiotherapy (IMRT). Participants will be instructed to orally administer the spirulina-derived product or placebo solution four times daily, starting from the first day of radiotherapy and continuing throughout the RT course. After each administration, patients must refrain from eating, drinking, or performing oral intake for at least 1 hour to maximize mucosal contact time of the intervention. The study will compare the spirulina-derived product group with the placebo group to determine the potential benefits of this spirulina-based intervention in preventing and managing radiotherapy-related esophagitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
70
An oral hydrogel formulated with purified spirulina-derived exosomes.
The placebo oral hydrogel will be formulated with inactive ingredients matched in appearance and flavor profile to the active spirulina-derived product.
Patient eligibility was defined as a diagnosis of esophageal cancer with a treatment plan involving radiotherapy (radiotherapy alone or concurrent chemoradiotherapy) using intensity-modulated radiotherapy (IMRT).
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The incidence of grade ≥2 radiation-induced esophagitis (RTOG criteria).
Radiation esophagitis is assessed by trained radiotherapists according to the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria. The RTOG criteria categorize acute esophageal toxicity into grades 0-4, with a higher grade indicating more severe symptoms. Grade 0 represents no change over baseline; grade 1 represents mild dysphagia or odynophagia requiring topical anesthetic or non-narcotic analgesics/soft diet; grade 2 represents moderate dysphagia or odynophagia requiring narcotic analgesics/pureed or liquid diet; grade 3 represents severe dysphagia or odynophagia with dehydration or weight loss (\>15% from pre-treatment baseline) requiring nasogastric feeding tube, intravenous fluids, or hyperalimentation; and grade 4 represents complete obstruction, ulceration, perforation, or fistula formation.
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks to 14.5 weeks.
Duration of Grade ≥2 Radiation Esophagitis
Toxicity Monitoring: Radiation oncologists or research nurses, uniformly trained, will assess and record the specific grade of esophagitis in patients at predefined time points, strictly adhering to the RTOG Acute Radiation Morbidity Scoring Criteria. Start Point Determination: The date when esophagitis is first recorded as grade ≥2 during the observation period is defined as the start date of the toxicity event. End Point Determination: The date when esophagitis is first recorded as having decreased and subsequently maintained at grade 1 or 0 in follow-up assessments is defined as the end date (i.e., recovery date) of the toxicity event. Duration Calculation: The duration of a single event is calculated as: End Date - Start Date. If the patient's esophagitis grade has not decreased to grade 0 by the end of the observation period (8 weeks after radiotherapy completion), the duration data for that patient will be treated as censored data.
Time frame: From the start of radiotherapy (baseline) to 2 months after treatment completion. The total evaluation period is approximately 14 to 14.5 weeks.
Time to Onset of Grade ≥2 Esophagitis
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Toxicity Monitoring: Radiation oncologists or research nurses, uniformly trained, will assess and record the specific grade of esophagitis in patients at predefined time points, strictly adhering to the RTOG Acute Radiation Morbidity Scoring Criteria. Onset Point Determination: The date when esophagitis is first recorded as grade ≥2 during the observation period is defined as the onset date of this toxicity event. Assessment Time Window: From the start of radiotherapy until 8 weeks after radiotherapy completion. To accurately capture the timing of toxicity onset, assessments are planned twice weekly during radiotherapy and once weekly during the follow-up period after radiotherapy completion. Handling of Special Cases: If a patient has not experienced grade ≥2 esophagitis by the end of the observation period (8 weeks post-radiotherapy), the time data for this endpoint will be treated as censored data.
Time frame: From the start of radiotherapy (baseline) to 2 months after treatment completion. The total evaluation period is approximately 14 to 14.5 weeks.
Adverse events
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks to 14.5 weeks.