Observational studyJournal of patient-reported outcomes2025
Patient- and clinician-reported acute radiation-induced diarrhoea in patients with prostate cancer during curative external radiation therapy: A prospective observational cohort study.
Observational study in Journal of patient-reported outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05684432 (Frequency and Classification of Radiation-induced Diarrhoea in Patients With Prostate and Rectal Cancer During Curative External Radiotherapy), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Frequency and Classification of Radiation-induced Diarrhoea in Patients With Prostate and Rectal Cancer During Curative External Radiotherapy
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundAcute radiation-induced diarrhoea (RID) typically develops from gut mucosa inflammation within 2 weeks of external beam radiation therapy (EBRT) to the pelvis. The Common Terminology Criteria for Adverse Events (CTCAE) commonly assesses RID. In patients with prostate cancer undergoing curative EBRT, acute RID was evaluated using both a clinician-reported outcome (ClinRO)-CTCAE, and a patient-reported (PRO) stool diary.
methodsDuring 2022–2024, 40 newly diagnosed patients with prostate cancer receiving curative EBRT were enrolled at the Oncology Departments in two centres. CTCAE was assessed at baseline (week 1), at end of EBRT (week 8 or 9), 2 weeks after end of EBRT (week 10 or 11), and 8 weeks after end of EBRT (week 16 or 17). Simultaneously, patients maintained a daily PRO diary from baseline to week 10, and at week 16. Patients’ registration of stool frequency was converted to grades according to the CTCAE criteria.
resultsThe clinicians assessed all 40 patients with RID Grade 0/1 using CTCAE, whereas the PRO stool diary showed 29/40 with Grade 0/1, 6/40 with Grade 2, and 5/40 with Grade 3. Grade 2 appeared in week 2 and Grade 3 in week 4. There was a significant difference (p < 0.001) between CTCAE and PRO grades from baseline to week 16 or 17. No correlation was observed between irradiation data and RID Grades 2/3. Significant weight loss differences were noted from baseline to week 8 or 9 between patients with RID Grades 0/1 and those with Grades 2/3.
conclusionAccording to the PRO stool diary, one in four patients with prostate cancer undergoing curative EBRT experienced acute RID Grade 2/3, but none with ClinRO CTCAE. A PRO stool diary effectively monitored the onset, course of acute RID, and body weight changes. The CTCAE does not adequately assess acute RID and needs PRO stool diary supplementation.
trial registrationClinicaltrials.gov, NCT05684432. Registered 5 January 2023.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.