Malignant NeoplasmPhase 3FIDURANCT04534075
Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial
A Phase 3 study of Malignant Neoplasm and Malignant Neoplasm of Rectum, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The investigators hypothesize that an increase in dietary fiber intake during radiation therapy may provide better long-term intestinal health for the cancer survivor. If the hypothesis is not correct, the increased intake may only mean an increase in acute side effects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Neoplasm, Malignant Neoplasm of Rectum, Malignant Neoplasm of Anus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- 1 siteSweden
- Study dates
- 2 Sep 2020to 14 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned preoperative (neoadjuvant) or curative radiation therapy for a tumor in the pelvic cavity (including all forms of gynecological cancer, colorectal cancer, anal cancer, prostate cancer, and urinary bladder cancer).
Who cannot join
- Preoperative stoma which, according to the attending physician, prevents participation
- Difficulty swallowing or ileus conditions which, according to the treating physician, prevent participation
- Cognitive dysfunction which, according to the treating physician, prevents participation
- Need for an interpreter to communicate in Swedish
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Jubileumskliniken, Sahlgrenska University Hospital
Gothenburg, 413 45
About this study
Official title: Dietary Fiber During Radiotherapy and Intestinal Inflammation - a Placebo-controlled Randomized Trial (FIDURA)
The investigators hypothesize that an increase in dietary fiber intake during radiation therapy may provide better long-term intestinal health for the cancer survivor. If the hypothesis is not correct, the increased intake may only mean an increase in acute side effects. All participants are advised to consume at least 16 g of dietary fiber/day via food. In addition, participants are invited to take capsules that together contain either 5.5 g of dietary fiber from psyllium husk or placebo.
Read the detailed description
The overall working hypothesis is that intake of dietary fiber during radiotherapy can mitigate or hinder end states or the triggering of long-lasting pathophysiological processes that decreases intestinal health in the cancer survivor. If correct, there is a dose-effect relationship to be documented. Moreover, if correct, different kinds of dietary fibers may have different effects. Mechanisms for the mitigatory effects may be that dietary fiber helps to preserve the two protective mucus layers and hinder gut-wall starvation. Lack of protection, as well as gut-wall starvation, may decrease the gut walls' integrity. That, in turn, may enhance bacterial migration from the lumen into the gut wall, causing unnecessary inflammation. This inflammation may, in turn, lead to a number of different pathophysiological processes, including a chronic self-propagating low-grade inflammation. Clinical experience suggests the intake of dietary fiber during radiotherapy may increase acute intestinal side effects. Our own data suggest a modest, if any, increase by dietary fiber.
Through recipes of tasty meals by price-winning chefs and general advice, the investigators guide the participant to try to consume at least 16 g of dietary fiber per day via food. The guidance takes place through telephone calls, calls via video link, and text on a website or paper material. The participant gets access to a mobile application that measures the daily intake of dietary fiber. Dietary fiber is ingested in 15 capsules with psyllium husk which contains a total of 5.5 g of dietary fiber. The investigators ask the participant to take the capsules two weeks before radiotherapy, during radiotherapy, and to stop four weeks after the end of radiotherapy. Placebo capsules (maltodextrin) are taken in the same way. To document the frequency of acute side effects, and what symptoms they cause, the participant is asked to report patient-reported outcomes once a week via a mobile application. They are also welcome to report side effects to the study office.
One month after the end of radiotherapy, the degree of inflammation is measured via markers in the blood and feces. One year after the end of radiotherapy, intestinal health is measured via patient-reported outcomes. Blood and feces are collected and patient-reported outcomes are reported in questionnaires and a mobile application before, during, and at least one year after the end of radiotherapy. This data will be a source of in-depth analysis. Radiotherapy gives rise to increased intensity of five different syndromes, fecal-leakage syndrome, urgency syndrome, uncontrolled flatulence, excess mucus discharge, and anal blood discharge. Damage of nerves and small vessels, weakening the anal-sphincter function by muscle fibers turning into the connective tissue (fibrosis), may explain some of the intensity of the fecal-leakage syndrome. An ongoing self-propagating low-grade inflammation, small-vessel and nerve damage in the gut wall may be related to urgency. Reasonably the microbiome, and the communication between the microbiome and the gut wall, is related to uncontrolled flatulence and excess mucus discharge. It is not known to what extent telangiectasias on a fibrotic inner gut wall explains anal blood discharge. Ad hoc studies in FIDURA will explore suggested mechanisms.
An interim analysis will be performed for the primary outcome to identify if there is any effect of the intervention, to decide whether to continue or terminate the inclusion of patients in the study. The concentration of c-reactive protein will be analyzed for all included patients who have donated blood to date (May 2023). To ensure that the blinding is not revealed, all analyses (biochemical and statistical) will be made by external personnel not included in the research group. The capsules are marked with X and Y, and the code for which is intervention or placebo will not be revealed even for the external personnel performing the interim analysis.
- Conditions
- Malignant Neoplasm, Malignant Neoplasm of Rectum, Malignant Neoplasm of Anus, Malignant Neoplasm of Urinary Bladder, Malignant Neoplasm of Cervix, Malignant Neoplasm of Ovary
- Being tested
- Capsules containing either dietary fiber or placebo
- Keywords
- Radiotherapy, Irradiation, Radiation therapy, Dietary fiber, Psyllium husk, Placebo-controlled, Double-blind, Randomized, Patient-reported outcomes, ePROMS, Gut-wall inflammation, Late adverse effects, Late effects, Treatment-induced cancer survivorship diseases, Treatment-induced cancer survivorship syndromes, Intestinal health, Bowel health, Urgency, Leakage, Mucus
- Medical subject headings
- Neoplasms, Rectal Neoplasms, Anus Neoplasms, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsules containing either dietary fiber or placeboBiological
The participants are invited to eat 15 capsules per day. The capsules either contain dietary fiber from psyllium husk or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Additional dietary fiber through Psyllium husk | Experimental | The participants are allocated to intake the fifteen capsules per day, for example, five capsules three times per day. Altogether the fifteen capsules contains 5.5 g dietary fiber in psyllium husk. Receives: Biological: Capsules containing either dietary fiber or placebo |
| Placebo (no additional dietary fiber) | Placebo comparator | The participants are allocated to intake the fifteen capsules per day, for example, five capsules three times per day. The capsules contain placebo (maltodextrin) and have a similar look as in the experimental arm. Receives: Biological: Capsules containing either dietary fiber or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sign of inflammation i blood
Concentration of c-reactive protein in plasma or serum
Measured: One month after the end of radiotherapy
Intensity of the urgency syndrome
Patient-reported outcomes through a validated questionnaire. The metric for the intensity of the urgency syndrome weighs the frequency of several symptoms by factor loadings, as described in PubMed ID 28158314. Examples of the previous usage can be seen in PubMed ID 28366105 and PubMed ID 30601820.
Measured: One year after the end of radiotherapy
Secondary outcomes (4)
Tolerance to additional dietary fiber
Deviation from the recommended intake of 15 capsules per day
Measured: During radiotherapy
Signs of inflammation i blood
Concentration of selected markers in blood and feces. The selection of cytokines and chemokines for this outcome is work in progress 26 august 2020 and will be be given as updated information later on. In feces we will primarily use elastase and calprotectin.
Measured: One month after the end of radiotherapy
Intensity of the fecal-leakage syndrome, uncontrolled flatulence, excess mucus discharge and blood
Patient-reported outcomes through a validated questionnaire. The metric for the intensity of the syndromes weighs the frequency of several symptoms by factor loadings, as described in PubMed ID 28158314. Examples of the previous usage can be seen in PubMed ID 28366105 and PubMed ID 30601820.
Measured: One year after the end of radiotherapy
Acute side-effects
Distress from gastrointestinal symptoms as reported through a mobile phone application (ePROMS). Primarily we ask for defecation frequency, stool consistency (Bristol Scale), and frequency of abdominal pain. The participants may also report other side-effects, either by the mobile phone application, video link, or telephone with the study secretariat.
Measured: During radiotherapy, primarily during week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start2 Sep 2020
- Primary completion14 Sep 2024
- Study completion14 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random allocation of patients and blinding of researchers, patients, healthcare professionals and outcome assessors.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, VGregion, The Sjöberg Foundation
- Responsible party
- Principal investigator, Gunnar Steineck, Sahlgrenska University Hospital
- Investigators
- Gunnar N Steineck, MD, PhD, Principal investigator, Göteborg UniversityMaria Hedelin, PhD, Study chair, Göteborg UniversityCecilia Bull, PhD, Study chair, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534075
- Sponsor's protocol ID
- ALFGBG-926 421
- Other IDs
- 2018-02966, 2020-01-07-02, 2018
- Acronym
- FIDURA
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2020
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As soon as we we have started publishing data we will successively make our data available to other researchers.
Publications
Patel P, Malipatlolla DK, Devarakonda S, Bull C, Rascon A, Nyman M, Stringer A, Tremaroli V, Steineck G, Sjoberg F. Dietary Oat Bran Reduces Systemic Inflammation in Mice Subjected to Pelvic Irradiation. Nutrients. 2020 Jul 22;12(8):2172. doi: 10.3390/nu12082172.
PubMed 32707913Malipatlolla DK, Patel P, Sjoberg F, Devarakonda S, Kalm M, Angenete E, Lindskog EB, Grander R, Persson L, Stringer A, Wilderang U, Swanpalmer J, Kuhn HG, Steineck G, Bull C. Long-term mucosal injury and repair in a murine model of pelvic radiotherapy. Sci Rep. 2019 Sep 24;9(1):13803. doi: 10.1038/s41598-019-50023-4.
PubMed 31551503Hedelin M, Skokic V, Wilderang U, Ahlin R, Bull C, Sjoberg F, Dunberger G, Bergmark K, Stringer A, Steineck G. Intake of citrus fruits and vegetables and the intensity of defecation urgency syndrome among gynecological cancer survivors. PLoS One. 2019 Jan 2;14(1):e0208115. doi: 10.1371/journal.pone.0208115. eCollection 2019.
PubMed 30601820Ahlin R, Sjoberg F, Bull C, Steineck G, Hedelin M. [Differing dietary advice are given to gynaecological and prostate cancer patients receiving radiotherapy in Sweden]. Lakartidningen. 2018 Oct 9;115:FALY. Swedish.
PubMed 30325475Sjoberg F, Malipatlolla DK, Patel P, Wilderang U, Kalm M, Steineck G, Bull C. Elastase as a potential biomarker for radiation-induced gut wall injury of the distal bowel in an experimental mouse model. Acta Oncol. 2018 Aug;57(8):1025-1030. doi: 10.1080/0284186X.2018.1438652. Epub 2018 Feb 15.
PubMed 29447028Bull C, Malipatlolla D, Kalm M, Sjoberg F, Alevronta E, Grander R, Sultanian P, Persson L, Bostrom M, Eriksson Y, Swanpalmer J, Wold AE, Blomgren K, Bjork-Eriksson T, Steineck G. A novel mouse model of radiation-induced cancer survivorship diseases of the gut. Am J Physiol Gastrointest Liver Physiol. 2017 Nov 1;313(5):G456-G466. doi: 10.1152/ajpgi.00113.2017. Epub 2017 Jul 20.
PubMed 28729245Steineck G, Sjoberg F, Skokic V, Bull C, Wilderang U, Alevronta E, Dunberger G, Bergmark K, Jornsten R. Late radiation-induced bowel syndromes, tobacco smoking, age at treatment and time since treatment - gynecological cancer survivors. Acta Oncol. 2017 May;56(5):682-691. doi: 10.1080/0284186X.2017.1307519. Epub 2017 Apr 1.
PubMed 28366105Steineck G, Skokic V, Sjoberg F, Bull C, Alevronta E, Dunberger G, Bergmark K, Wilderang U, Oh JH, Deasy JO, Jornsten R. Identifying radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer survivors. PLoS One. 2017 Feb 3;12(2):e0171461. doi: 10.1371/journal.pone.0171461. eCollection 2017.
PubMed 28158314Steineck G, Schmidt H, Alevronta E, Sjoberg F, Bull CM, Vordermark D. Toward Restored Bowel Health in Rectal Cancer Survivors. Semin Radiat Oncol. 2016 Jul;26(3):236-50. doi: 10.1016/j.semradonc.2016.03.002. Epub 2016 Mar 18.
PubMed 27238476Lind H, Alevronta E, Steineck G, Waldenstrom AC, Nyberg T, Olsson C, Wilderang U, Dunberger G, Al-Abany M, Avall-Lundqvist E. Defecation into clothing without forewarning and mean radiation dose to bowel and anal-sphincter among gynecological cancer survivors. Acta Oncol. 2016 Nov;55(11):1285-1293. doi: 10.1080/0284186X.2016.1176247. Epub 2016 May 13.
PubMed 27173757Thor M, Olsson CE, Oh JH, Petersen SE, Alsadius D, Bentzen L, Pettersson N, Muren LP, Waldenstrom AC, Hoyer M, Steineck G, Deasy JO. Relationships between dose to the gastro-intestinal tract and patient-reported symptom domains after radiotherapy for localized prostate cancer. Acta Oncol. 2015;54(9):1326-34. doi: 10.3109/0284186X.2015.1063779. Epub 2015 Sep 4.
PubMed 26340136Alsadius D, Olsson C, Pettersson N, Tucker SL, Wilderang U, Steineck G. Patient-reported gastrointestinal symptoms among long-term survivors after radiation therapy for prostate cancer. Radiother Oncol. 2014 Aug;112(2):237-43. doi: 10.1016/j.radonc.2014.08.008. Epub 2014 Sep 4.
PubMed 25201126Ahlin R, Bergmark K, Bull C, Devarakonda S, Landberg R, Sigvardsson I, Sjoberg F, Skokic V, Steineck G, Hedelin M. A Preparatory Study for a Randomized Controlled Trial of Dietary Fiber Intake During Adult Pelvic Radiotherapy. Front Nutr. 2021 Dec 7;8:756485. doi: 10.3389/fnut.2021.756485. eCollection 2021.
PubMed 34950688
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Fiber During Radiotherapy and Intestinal Inflammation - a Placebo-controlled Randomized Trial (FIDURA)
- ClinicalTrials.gov ID
- NCT04534075
- Acronym / sponsor ID
- FIDURA / ALFGBG-926 421
- Conditions
- Malignant Neoplasm, Malignant Neoplasm of Rectum, Malignant Neoplasm of Anus, Malignant Neoplasm of Urinary Bladder, Malignant Neoplasm of Cervix, Malignant Neoplasm of Ovary
- Keywords
- Radiotherapy, Irradiation, Radiation therapy, Dietary fiber, Psyllium husk, Placebo-controlled, Double-blind, Randomized
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- The Swedish Research Council, VGregion, The Sjöberg Foundation
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 14 Sep 2024 (actual)
- Study completion
- 14 Sep 2024 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that an increase in dietary fiber intake during radiation therapy may provide better long-term intestinal health for the cancer survivor. If the hypothesis is not correct, the increased intake may only mean an increase in acute side effects. All participants are advised to consume at least 16 g of dietary fiber/day via food. In addition, participants are invited to take capsules that together contain either 5.5 g of dietary fiber from psyllium husk or placebo.
Detailed description
The overall working hypothesis is that intake of dietary fiber during radiotherapy can mitigate or hinder end states or the triggering of long-lasting pathophysiological processes that decreases intestinal health in the cancer survivor. If correct, there is a dose-effect relationship to be documented. Moreover, if correct, different kinds of dietary fibers may have different effects. Mechanisms for the mitigatory effects may be that dietary fiber helps to preserve the two protective mucus layers and hinder gut-wall starvation. Lack of protection, as well as gut-wall starvation, may decrease the gut walls' integrity. That, in turn, may enhance bacterial migration from the lumen into the gut wall, causing unnecessary inflammation. This inflammation may, in turn, lead to a number of different pathophysiological processes, including a chronic self-propagating low-grade inflammation. Clinical experience suggests the intake of dietary fiber during radiotherapy may increase acute intestinal side effects. Our own data suggest a modest, if any, increase by dietary fiber.
Through recipes of tasty meals by price-winning chefs and general advice, the investigators guide the participant to try to consume at least 16 g of dietary fiber per day via food. The guidance takes place through telephone calls, calls via video link, and text on a website or paper material. The participant gets access to a mobile application that measures the daily intake of dietary fiber. Dietary fiber is ingested in 15 capsules with psyllium husk which contains a total of 5.5 g of dietary fiber. The investigators ask the participant to take the capsules two weeks before radiotherapy, during radiotherapy, and to stop four weeks after the end of radiotherapy. Placebo capsules (maltodextrin) are taken in the same way. To document the frequency of acute side effects, and what symptoms they cause, the participant is asked to report patient-reported outcomes once a week via a mobile application. They are also welcome to report side effects to the study office.
One month after the end of radiotherapy, the degree of inflammation is measured via markers in the blood and feces. One year after the end of radiotherapy, intestinal health is measured via patient-reported outcomes. Blood and feces are collected and patient-reported outcomes are reported in questionnaires and a mobile application before, during, and at least one year after the end of radiotherapy. This data will be a source of in-depth analysis. Radiotherapy gives rise to increased intensity of five different syndromes, fecal-leakage syndrome, urgency syndrome, uncontrolled flatulence, excess mucus discharge, and anal blood discharge. Damage of nerves and small vessels, weakening the anal-sphincter function by muscle fibers turning into the connective tissue (fibrosis), may explain some of the intensity of the fecal-leakage syndrome. An ongoing self-propagating low-grade inflammation, small-vessel and nerve damage in the gut wall may be related to urgency. Reasonably the microbiome, and the communication between the microbiome and the gut wall, is related to uncontrolled flatulence and excess mucus discharge. It is not known to what extent telangiectasias on a fibrotic inner gut wall explains anal blood discharge. Ad hoc studies in FIDURA will explore suggested mechanisms.
An interim analysis will be performed for the primary outcome to identify if there is any effect of the intervention, to decide whether to continue or terminate the inclusion of patients in the study. The concentration of c-reactive protein will be analyzed for all included patients who have donated blood to date (May 2023). To ensure that the blinding is not revealed, all analyses (biochemical and statistical) will be made by external personnel not included in the research group. The capsules are marked with X and Y, and the code for which is intervention or placebo will not be revealed even for the external personnel performing the interim analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Random allocation of patients and blinding of researchers, patients, healthcare professionals and outcome assessors.
| Arm | Type | Receives |
|---|---|---|
| Additional dietary fiber through Psyllium husk | Experimental | Biological: Capsules containing either dietary fiber or placeboThe participants are allocated to intake the fifteen capsules per day, for example, five capsules three times per day. Altogether the fifteen capsules contains 5.5 g dietary fiber in psyllium husk. |
| Placebo (no additional dietary fiber) | Placebo comparator | Biological: Capsules containing either dietary fiber or placeboThe participants are allocated to intake the fifteen capsules per day, for example, five capsules three times per day. The capsules contain placebo (maltodextrin) and have a similar look as in the experimental arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planned preoperative (neoadjuvant) or curative radiation therapy for a tumor in the pelvic cavity (including all forms of gynecological cancer, colorectal cancer, anal cancer, prostate cancer, and urinary bladder cancer).
Key exclusion criteria (4 listed)
- Preoperative stoma which, according to the attending physician, prevents participation
- Difficulty swallowing or ileus conditions which, according to the treating physician, prevent participation
- Cognitive dysfunction which, according to the treating physician, prevents participation
- Need for an interpreter to communicate in Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsules containing either dietary fiber or placeboThe participants are invited to eat 15 capsules per day. The capsules either contain dietary fiber from psyllium husk or placebo. | Biological | Additional dietary fiber through Psyllium husk, Placebo (no additional dietary fiber) |
Primary outcome
Sign of inflammation i blood
Time frame: One month after the end of radiotherapy
Concentration of c-reactive protein in plasma or serum
Intensity of the urgency syndrome
Time frame: One year after the end of radiotherapy
Patient-reported outcomes through a validated questionnaire. The metric for the intensity of the urgency syndrome weighs the frequency of several symptoms by factor loadings, as described in PubMed ID 28158314. Examples of the previous usage can be seen in PubMed ID 28366105 and PubMed ID 30601820.
4 secondary outcomes
Tolerance to additional dietary fiber
Time frame: During radiotherapy
Signs of inflammation i blood
Time frame: One month after the end of radiotherapy
Intensity of the fecal-leakage syndrome, uncontrolled flatulence, excess mucus discharge and blood
Time frame: One year after the end of radiotherapy
Acute side-effects
Time frame: During radiotherapy, primarily during week 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 32707913Patel P, Malipatlolla DK, Devarakonda S, Bull C, Rascon A, Nyman M, Stringer A, Tremaroli V, Steineck G, Sjoberg F. Dietary Oat Bran Reduces Systemic Inflammation in Mice Subjected to Pelvic Irradiation. Nutrients. 2020 Jul 22;12(8):2172. doi: 10.3390/nu12082172.
- Background: PubMed 31551503Malipatlolla DK, Patel P, Sjoberg F, Devarakonda S, Kalm M, Angenete E, Lindskog EB, Grander R, Persson L, Stringer A, Wilderang U, Swanpalmer J, Kuhn HG, Steineck G, Bull C. Long-term mucosal injury and repair in a murine model of pelvic radiotherapy. Sci Rep. 2019 Sep 24;9(1):13803. doi: 10.1038/s41598-019-50023-4.
- Background: PubMed 30601820Hedelin M, Skokic V, Wilderang U, Ahlin R, Bull C, Sjoberg F, Dunberger G, Bergmark K, Stringer A, Steineck G. Intake of citrus fruits and vegetables and the intensity of defecation urgency syndrome among gynecological cancer survivors. PLoS One. 2019 Jan 2;14(1):e0208115. doi: 10.1371/journal.pone.0208115. eCollection 2019.
- Background: PubMed 30325475Ahlin R, Sjoberg F, Bull C, Steineck G, Hedelin M. [Differing dietary advice are given to gynaecological and prostate cancer patients receiving radiotherapy in Sweden]. Lakartidningen. 2018 Oct 9;115:FALY. Swedish.
- Background: PubMed 29447028Sjoberg F, Malipatlolla DK, Patel P, Wilderang U, Kalm M, Steineck G, Bull C. Elastase as a potential biomarker for radiation-induced gut wall injury of the distal bowel in an experimental mouse model. Acta Oncol. 2018 Aug;57(8):1025-1030. doi: 10.1080/0284186X.2018.1438652. Epub 2018 Feb 15.
- Background: PubMed 28729245Bull C, Malipatlolla D, Kalm M, Sjoberg F, Alevronta E, Grander R, Sultanian P, Persson L, Bostrom M, Eriksson Y, Swanpalmer J, Wold AE, Blomgren K, Bjork-Eriksson T, Steineck G. A novel mouse model of radiation-induced cancer survivorship diseases of the gut. Am J Physiol Gastrointest Liver Physiol. 2017 Nov 1;313(5):G456-G466. doi: 10.1152/ajpgi.00113.2017. Epub 2017 Jul 20.
- Background: PubMed 28366105Steineck G, Sjoberg F, Skokic V, Bull C, Wilderang U, Alevronta E, Dunberger G, Bergmark K, Jornsten R. Late radiation-induced bowel syndromes, tobacco smoking, age at treatment and time since treatment - gynecological cancer survivors. Acta Oncol. 2017 May;56(5):682-691. doi: 10.1080/0284186X.2017.1307519. Epub 2017 Apr 1.
- Background: PubMed 28158314Steineck G, Skokic V, Sjoberg F, Bull C, Alevronta E, Dunberger G, Bergmark K, Wilderang U, Oh JH, Deasy JO, Jornsten R. Identifying radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer survivors. PLoS One. 2017 Feb 3;12(2):e0171461. doi: 10.1371/journal.pone.0171461. eCollection 2017.
- Background: PubMed 27238476Steineck G, Schmidt H, Alevronta E, Sjoberg F, Bull CM, Vordermark D. Toward Restored Bowel Health in Rectal Cancer Survivors. Semin Radiat Oncol. 2016 Jul;26(3):236-50. doi: 10.1016/j.semradonc.2016.03.002. Epub 2016 Mar 18.
- Background: PubMed 27173757Lind H, Alevronta E, Steineck G, Waldenstrom AC, Nyberg T, Olsson C, Wilderang U, Dunberger G, Al-Abany M, Avall-Lundqvist E. Defecation into clothing without forewarning and mean radiation dose to bowel and anal-sphincter among gynecological cancer survivors. Acta Oncol. 2016 Nov;55(11):1285-1293. doi: 10.1080/0284186X.2016.1176247. Epub 2016 May 13.
- Background: PubMed 26340136Thor M, Olsson CE, Oh JH, Petersen SE, Alsadius D, Bentzen L, Pettersson N, Muren LP, Waldenstrom AC, Hoyer M, Steineck G, Deasy JO. Relationships between dose to the gastro-intestinal tract and patient-reported symptom domains after radiotherapy for localized prostate cancer. Acta Oncol. 2015;54(9):1326-34. doi: 10.3109/0284186X.2015.1063779. Epub 2015 Sep 4.
- Background: PubMed 25201126Alsadius D, Olsson C, Pettersson N, Tucker SL, Wilderang U, Steineck G. Patient-reported gastrointestinal symptoms among long-term survivors after radiation therapy for prostate cancer. Radiother Oncol. 2014 Aug;112(2):237-43. doi: 10.1016/j.radonc.2014.08.008. Epub 2014 Sep 4.
- Individual participant dataSharing planned: Yes. As soon as we we have started publishing data we will successively make our data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar N Steineck, MD, PhD principal investigator
Göteborg University
Maria Hedelin, PhD study chair
Göteborg University
Cecilia Bull, PhD study chair
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Malignant Neoplasm and Malignant Neoplasm of Rectum, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sign of inflammation i blood (time frame: One month after the end of radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534075, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.