Trial Title:
Radiation-induced Diarrhoea During Curative EBRT of Prostate and Rectal Cancer
NCT ID:
NCT05684432
Condition:
Radiation-induced Diarrhoea in Prostate and Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Diarrhea
Conditions: Keywords:
Acute radiation-induced diarrhoea
Curative EBRT
Prostate cancer
Rectal cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No intervention
Description:
No intervention
Arm group label:
Prostate and rectal cancer patients
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.
Detailed description:
1. Background Prostate and rectal cancer are among the most common cancer types in
Denmark and make up the majority of patients who receive curative radiation therapy
of the small pelvis. A well-known side effect of external beam radiation therapy
(EBRT) to the pelvis is radiation-induced diarrhoea (RID). When ionising radiation
is given to the patient, both tumour and the surrounding cells are damaged. Thus,
irradiating prostate and rectal cancer will inevitably lead to the damage of the
nearby gut mucosa cellular components. This cellular damage is causing the RID. RID
is reported as the problem with the greatest impact on health-related quality of
life (QoL) and social behaviour.
Up to approx. 70% of patients who receive pelvic radiation experience acute RID. It
usually occurs two weeks after start of EBRT and peaks during 4-5 weeks. Acute RID
may cease a few weeks after the end of EBRT but increases the risk of developing
chronic RID.
Recently, a systematic Cochrane review reveals low evidence for dietary
interventions in RID due to few studies and low scientific quality. A serious
drawback of the Cochrane review was that it included studies prior of 2005, with
radiotherapy given both pre- and post-surgery, as well as with radiotherapy
techniques resulting in higher doses to the normal tissue. It is well known that the
volume of the radiation field greatly impacts the severity of RID and newer
radiation techniques allow smaller volume fields.
There is a lack of consensus about how acute RID is reported, such as definition of
RID (frequency), classification and the changes during EBRT. There is also a lack of
knowledge of changes in microbiomes which can contribute to RID. The role of dietary
intervention during EBRT could also influence RID.
2. Aim The aim of this prospective observation study is to investigate the frequency,
severity and changes of acute RID in patients with prostate and rectal cancer as
well as the role of nutrition and changes in microbiome during curative EBRT.
3. Method This is an observational multicenter study of acute RID in patients with
prostate and rectal cancer during curative EBRT. The study will take place in
parallel with the patients' EBRT, which is ongoing on weekdays over 39 days for
patients with prostate cancer and 28 days for patients with rectal cancer.
Study procedure Candidates will be identified according to the inclusion and exclusion
criteria. The patients will be informed orally and in written form by a doctor or project
nurse at the first oncology appointment.
The observations will start at baseline and concomitant with EBRT. All examinations and
observations will be carried out in parallel with the patient's EBRT.
Data collection
1. Patient data: Civil status, age, sex, comorbidities, smoking, histopathology data:
Primary diagnosis, date, stage, Electronic patient's record (EPR) 2. Treatment data:
Treatment start and end date, fractionation and total dose (Gy), field size and
anatomical location, EPR 3. Clinical examinations: ECOG performance status, body
weight, height, rectal exploration, rectal haemorrhage or mucus, bloating,
flatulence, obstipation, abdominal pain or tenesmus, faecal or urine incontinence,
EPR, Common Terminology Criteria for Adverse Events (CTCAE) 4. Medication:
Anti-diarrhoeal medication, laxatives, antibiotics, opioids, EPR 5. Frequency and
classification of RID, body weight, Bristol Stool Scale and patient reported stool
diary 6. Nutrition screening: Nutrition-related symptoms, dietary intake
development, PG-SGA-short form 7. Dietary assessment: 3-day food records, online
food database (Vitakost, 2006-2018, Denmark 8. Patient's physical activity,
International Physical Activity Questionnaire (IPAQ-short form) 9. Quality of life
(QoL), EORTC QLQ-C30, EORTC QLQ-PRT20 questionnaires 10. Biochemistry: Routinely
blood samples collected at baseline will be obtained, EPR (biochemical record) 11.
Faecel samples only for patients treated in Aalborg: F-calprotectin, short chain
fatty acids. Samples will be frozen for subsequent microbial analysis, EPR
(microbiological record)
4. Statistical considerations It is expected to include at least 100 patients during
the inclusion period from 1 June 2022 to 31 December 2023. We expect to find above
30% of the patients with acute RID, why the required number of patients is estimated
as above. The data are processed descriptive, as current numbers and percentages.
Uni- and multivariate analyses will be conducted using the Stata software, version 16
(StataCorp, LLC, TX, USA).
5. Subjects Patients with prostate and rectal cancer patients commenced to start
curative EBRT, referred to the oncology department at Danish hospitals participating
in the study will be consecutively screened for study eligibility according to the
inclusion and exclusion criteria.
1. 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
2. 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
6. Risks, side effects and disadvantages in short and long term This observational
study does not include any risks for the included patients. Their treatment
will be carried out as standard of care. Disadvantages are only related to
answering the questionnaires and extra blood-samples and for Aalborg-patients
also the collection of stool-samples.
7. Information from patient records
The following data will be registered:
Civil status, age, sex, smoking, comorbidities, histopathologal data: primary
diagnosis, date, stage.
Treatment start and end date, fractionation and total dose (Gy), field size and
anatomical location.
Clinical examinations: ECOG performance status, rectal exploration, rectal
haemorrhage or mucus, bloating, flatulence, obstipation, abdominal pain or tenesmus,
faecal or urine incontinence.
8. Data collection The tools (PG-SGAshort form, IPAQ short form, EORTC QLQ-C30 and
EORTC QLQ-PRT20) will be sent to the patient's email address or security
electronic mailbox (e-Boks) via RedCAP. Patient's responses will be registered
directly in RedCAP.
Patient reported stool diary and 3-day food records will be handed out in paper
versions at the 1st visit at the radiation center. These paper versions will be
returned to the primary investigator via franked envelopes and the data recorded
will be registered in RedCAP. Data collected will be handled according to the Danish
law of data protection and Personal Data Act. It is the responsibility of the
principal investigator to ensure that the rules and regulations of data collection
and storage comply with the Personal Data Act.
9. Data storage The patient's personal identification/CPR number will be removed
and replaced by a code number.
All data will be stored in the MM-ICI-ABX research database in the system of the
Research Electronic Data Capture (REDCap) at the clinical research unit, Dept. of
Oncology, Aalborg University Hospital, the North Region of Denmark.
10. Data protection All data stored in the REDCap research data MM-ICI-ABX will be
handled according to the rules of Good Clinical Research Practice (27). The
research database will be stored at the Clinical Research Unit, Dept. of
Oncology, Aalborg University Hospital and owned by the Northern Region of
Denmark. The password will be established for the principal investigator only
(Mette Overgaard Holm). The members of the project group will handle the data
according to the Danish laws of personal data protection. The patient's
personal identification number will be removed and replaced of a code number
(anonymisation). The key document with information on both personal ID and code
number will be deposited at the clinical research unit project secretary
according to GDPR and the Danish laws of personal data protection.
11. Data deletion All data in this study will be deleted 5 years after publication
of all results.
12. Collaboration agreement Collaboration agreement will be made between the
principal investigator in the North Denmark Region and the participating local
investigators of the actual regions of Denmark (The Capital Region of Denmark,
Region Zealand and South Denmark Region).
The study will be performed between the North Denmark Region, the Capital Region of
Denmark, region Zealand and South Denmark Region. The study will be designed by all
responsible parts.
13. Economy The initiative for this project was taken by the project group,
employed at Aalborg University Hospital and Clinical Institute, Aalborg
University. Participants in the project group are financed (partial or
completely) through their employment at Aalborg University Hospital and
Clinical Institute, Aalborg University.
Funding of 320,000 DKK has been obtained from the Clinical Institute, Aalborg
University (research fund, U. Falkmer) and from the Region North Denmark of 86,000
DKK (research fund, M.O. Holm), as well as 191,850 DKK from the Danish Comprehensive
Cancer Center (DCCC) and will be used for salary for the PhD student (Mette
Overgaard Holm), statistician, as well as a coordinative staff from each
participating radiation therapy center. There is no economic benefit for neither the
participating departments nor the hospital employees.
The funders have no role in study design, data collection and analysis, and
decisions to publish, or preparation of the manuscript.
14. Compensation and/or other benefits to the subjects The patients will not be
offered any financial compensation or other benefits due to study
participation, nor travel expenses.
Patients participating in the study are covered by national regulation.
15. Publication The results regardless of positive, negative, and inconclusive
character will be published in international peer reviewed scientific journals
and in the PhD thesis of Mette Overgaard Holm.
16. Science ethics section All patients included in the study have signed their
information used for this clinical research project. The study is initiated as
an academic protocol of the project group. The members have no conflict of
interest. The approval will be applied for at the Scientific Ethics Committee
Northern Region of Denmark. The study protocol will be registered in
ClinicalTrial.gov and in the Region North Denmark.
17. Compensation scheme information Not relevant for this project.
Criteria for eligibility:
Study pop:
Patients treated with curative EBRT for prostate or rectal cancer
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aalborg University Hospital
Address:
City:
Aalborg
Zip:
9200
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Mette Overgaard Holm, MSc
Phone:
+45 97660259
Phone ext:
+45 97660259
Email:
mo.holm@rn.dk
Start date:
June 1, 2022
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Aalborg University Hospital
Agency class:
Other
Source:
Aalborg University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05684432
