drugset / Trial / NCT04534075
Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial
Phase 3
Completed
354 enrolled
Sahlgrenska University Hospital
Sjöbergstiftelsen · collabThe Swedish Research Council · collabVGregion · collab
RandomizedParallel-groupQuadruple-blindPrevention
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. 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.
Timeline
- Start
- 2020-09-02
- Primary completion
- 2024-09-14
- Completion
- 2024-09-14
Publications
- Background 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.
- Background Malipatlolla 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 Hedelin 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 Ahlin 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 Sjoberg 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 Bull 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 Steineck 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 Steineck 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 Steineck 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 Lind 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 Thor 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 Alsadius 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.
- Ahlin 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Psyllium husk | Unknown | 5.5 g | — |