Table 4.
Gastrointestinal mucositis assessment in clinical trials.
| Clinical trial |
|||||
|---|---|---|---|---|---|
| Standard chemotherapy | Pelvic radiotherapy | HSCT | Targeted agents | Immunotherapy | |
| Recommended tool for clinician assessment | CTCAE | WHO CTCAE |
Bristol stool chart | Bristol stool chart | Bristol stool chart |
| Frequency of assessment | At beginning of each cycle and weekly if practicable | Every 1–3 weeks | Daily (if in-patient) Weekly (if feasible in outpatient setting) |
Monthly | Monthly |
| Recommended PROM | PRO-CTCAE | PRO-CTCAE OM(W/D)Q | PRO-CTCAE | No questionnaire specifically validated, suggestion for PRO-CTCAE use | No questionnaire specifically validated, suggestion for PRO-CTCAE use |
| Frequency of assessment | Weekly | Weekly for PRO-CTCAE/OMWQ or daily for OMDQ | Weekly | Monthly | At each cycle |
| Biomarkers to consider | Plasma citrulline and/or gut microbiome composition | Plasma citrulline and/or gut microbiome composition | Plasma citrulline and/or gut microbiome composition | No biomarkers recommended | No biomarkers recommended |