Clinical trial · Observational
Radiation-induced Diarrhoea During Curative EBRT of Prostate and Rectal Cancer
Frequency and Classification of Radiation-induced Diarrhoea in Patients With Prostate and Rectal Cancer During Curative External Radiotherapy
NCT05684432CI-TRIAL-00085061PRECANUcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Approx. 80% of patients with prostate and rectal cancer who receive radiation therapy (RT) experience acute radiation-induced diarrhea (RID). RID has major impact on patients' quality of life, can lead to pause or early termination of RT and chronic diarrhea. RID is poorly described with few details of type and severity of RID in clinical practice and in the literature. We are conducting an observational study in patients in patients who receive curative EBRT radiation for prostate and rectal cancer to uncover the frequency and classifications of RID.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation-induced Diarrhoea in Prostate and Rectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Prostate and rectal cancer patients
- description
- Curative EBRT
- interventionNames
- Other: No intervention
Primary outcomes (1)
- measure
- Frequency and classification of radiation-induced diarrhrea in patients with prostate and rectal cancer during curative external radiotherapy
- timeFrame
- 1 June 2022 - 31 December 2023
- description
- Frequency of RID measured as mean number of stools per day/week, distribution daytime/night-time during EBRT. RID measured as Common Terminology Criteria (CTCAE)/Bristol Stool Scale (diarrhoea, rectal haemorrhage, bloating, abdominal pain, tenesmus, proctitis, rectal fissure, mucus, flatulence and faecal incontinence), score and use of antidiarrheal medication and laxatives (type, dose, start, stop). QoL measured during and following EBRT. Patient's nutrition, physical activity, biochemical measures and faecal samples.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically verified prostate or rectal adenocarcinoma 2. Commenced to start curative EBRT to the pelvis, with or without chemotherapy or with or without androgen deprivation therapy (ADT) 3. Performance status 0-1 4. ≥ 18 years of age 5. Understanding and acceptance of written and orally informed consent in Danish Exclusion Criteria: 1. Earlier treated with EBRT or other type of radiation to the pelvis 2. History of diagnosed inflammatory bowel disease 3. Colostomy 4. Pregnancy
References
Publications (23)
- RESULTMcBride WH, Schaue D. Radiation-induced tissue damage and response. J Pathol. 2020 Apr;250(5):647-655. doi: 10.1002/path.5389. Epub 2020 Feb 21. PMID 31990369
- RESULTAndreyev J. Gastrointestinal symptoms after pelvic radiotherapy: a new understanding to improve management of symptomatic patients. Lancet Oncol. 2007 Nov;8(11):1007-17. doi: 10.1016/S1470-2045(07)70341-8. PMID 17976611
- RESULTMuls AC. Acta Oncologica Lecture. Gastrointestinal consequences of cancer treatment and the wider context: a bad gut feeling. Acta Oncol. 2014 Mar;53(3):297-306. doi: 10.3109/0284186X.2013.873140. Epub 2014 Jan 27. PMID 24460087
- RESULTMorris KA, Haboubi NY. Pelvic radiation therapy: Between delight and disaster. World J Gastrointest Surg. 2015 Nov 27;7(11):279-88. doi: 10.4240/wjgs.v7.i11.279. PMID 26649150
- RESULTStacey R, Green JT. Radiation-induced small bowel disease: latest developments and clinical guidance. Ther Adv Chronic Dis. 2014 Jan;5(1):15-29. doi: 10.1177/2040622313510730. PMID 24381725
- RESULTAndreyev HJ, Davidson SE, Gillespie C, Allum WH, Swarbrick E; British Society of Gastroenterology; Association of Colo-Proctology of Great Britain and Ireland; Association of Upper Gastrointestinal Surgeons; Faculty of Clinical Oncology Section of the Royal College of Radiologists. Practice guidance on the management of acute and chronic gastrointestinal problems arising as a result of treatment for cancer. Gut. 2012 Feb;61(2):179-92. doi: 10.1136/gutjnl-2011-300563. Epub 2011 Nov 4. PMID 22057051
- RESULTKhalid U, McGough C, Hackett C, Blake P, Harrington KJ, Khoo VS, Tait D, Norman AR, Andreyev HJ. A modified inflammatory bowel disease questionnaire and the Vaizey Incontinence questionnaire are more sensitive measures of acute gastrointestinal toxicity during pelvic radiotherapy than RTOG grading. Int J Radiat Oncol Biol Phys. 2006 Apr 1;64(5):1432-41. doi: 10.1016/j.ijrobp.2005.10.007.