CompletedNot Applicable

Radiation-induced Diarrhoea During Curative EBRT of Prostate and Rectal Cancer

Denmark40 participantsStarted 2022-06-01

Plain-language summary

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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histopathologically verified prostate or rectal adenocarcinoma
. Commenced to start curative EBRT to the pelvis, with or without chemotherapy or with or without androgen deprivation therapy (ADT)
. Performance status 0-1
. ≥ 18 years of age
. Understanding and acceptance of written and orally informed consent in Danish

Exclusion criteria

. Earlier treated with EBRT or other type of radiation to the pelvis
. History of diagnosed inflammatory bowel disease

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT05684432

SponsorAalborg University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Radiation-induced Diarrhoea in Prostate and Rectal Cancer trials