Spirulina Derivative for Radiation Esophagitis

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.

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.

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.

Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version

Measurement Description: This indicator assesses the dynamic changes in the composition (relative abundance of microbial taxa) and alpha diversity (e.g., Shannon index, Chao1 index) of the salivary microbiota in cancer patients undergoing radiotherapy throughout the treatment process.

Measurement Methods:

Sample Collection: Non-stimulated whole saliva samples are collected from patients at specified time points using the spit method.

Laboratory Analysis: Total microbial DNA is extracted from the saliva samples. The V3-V4 hypervariable regions of the bacterial 16S rRNA gene are amplified via PCR, followed by sequencing using the Illumina high-throughput sequencing platform.

Bioinformatics Analysis: Raw sequencing data undergo quality control, denoising, and generation of amplicon sequence variants. These are then aligned and annotated against reference databases to analyze the community structure and diversity of the microbiota.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) This instrument is a 30-item patient-reported outcome (PRO) measure designed to evaluate core aspects of health-related quality of life in cancer patients, including 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, pain, nausea and vomiting), one global health status/quality of life scale, and 6 single-item symptom measures. Scores are linearly transformed to a range of 0-100. For the functional scales and the global health status scale, higher scores indicate better functional levels or quality of life; for the symptom scales/items, higher scores indicate greater symptom burden.

Description of Measurement Method:

The EORTC QLQ-OES18 is a patient-reported outcome (PRO) instrument specifically designed to assess disease-related symptoms and treatment-related side effects in patients with esophageal cancer. It comprises 18 items, organized into four multi-item subscales (dysphagia, eating, reflux, and pain) and six single-item measures (dry mouth, taste problems, coughing, speech problems, difficulty swallowing saliva, and hair loss). All subscale and single-item scores are linearly transformed to a 0-100 scale using a standardized scoring algorithm.

Interpretation of Scores:

For all subscales and single items, higher scores represent more severe symptoms or greater symptom burden.