Efficacy of a Spirulina Derivative in Preventing Radiation-Induced Esophagitis in Esophageal Cancer Patients Undergoing IMRT: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The incidence of grade ≥2 radiation-induced esophagitis (RTOG criteria).
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histopathologically confirmed malignant esophageal tumor and no distant metastasis;
- •Age ≥ 18 years;
- •ECOG (Eastern Cooperative Oncology Group) performance status score ≤ 2;
- •Scheduled to undergo definitive radiotherapy, neoadjuvant radiotherapy, or adjuvant radiotherapy for esophageal cancer;
- •Adequate hepatic, renal, and bone marrow function;
- •Signed informed consent form.
排除标准
- •History of prior thoracic radiotherapy.
- •Known allergy to spirulina or its derivatives, any component of the thermosensitive gel, or having a history of severe allergic predisposition.
- •Presence of esophageal or oral diseases assessed by the investigator before radiotherapy initiation that may affect the analysis of this study's results (e.g., reflux esophagitis, Barrett's esophagus, severe oral infection, recurrent aphthous ulcers, oral lichen planus, etc.).
- •Use of systemic antibacterial or antifungal medications within one week prior to the start of radiotherapy.
- •Planned concurrent use of medications that may exacerbate radiation-induced mucosal injury after radiotherapy initiation (e.g., anti-EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.).
- •Presence of severe underlying diseases of the cardiovascular, pulmonary, hepatic, renal, hematopoietic, or nervous systems (specific criteria for organ dysfunction are detailed in item 7 below), or conditions such as acute infection, uncontrolled autoimmune diseases, poorly controlled diabetes mellitus, etc., which, in the investigator's judgment, may increase study risks or interfere with result analysis.
- •Presence of significant organ dysfunction meeting any of the following criteria:
- •Hemoglobin < 80 g/L;
- •Neutrophil count < 1.0 × 10⁹/L;
- •Platelet count < 80 × 10⁹/L;
- •Serum total bilirubin ≥ 2 times the upper limit of normal (ULN);
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 times ULN;
- •Serum creatinine > 1.5 times ULN.
- •Pregnant or lactating women.
- •History of severe mental illness, alcohol abuse, or drug abuse.
- •Participation in other clinical trials within the past 3 months.
- •Any other condition deemed by the investigator as potentially rendering the subject unsuitable for participation in this study (e.g., extremely poor oral hygiene, poor compliance, etc.).
研究组 & 干预措施
Hydrogel of placebo
干预措施: Hydrogel of placebo (Drug)
Hydrogel of placebo
干预措施: Radiotherapy (Radiation)
Hydrogel of spirulina derivatives
干预措施: Hydrogel of spirulina-derived exosomes. (Drug)
Hydrogel of spirulina derivatives
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
The incidence of grade ≥2 radiation-induced esophagitis (RTOG criteria).
时间窗: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks to 14.5 weeks.
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.
次要结局
- Duration of Grade ≥2 Radiation Esophagitis(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(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(From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks to 14.5 weeks.)
研究者
Xingchen Peng
PhD, Professor
West China Hospital