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

NCT05684432 | Completed

• 1 other identifier: N-20210040
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiation-induced Diarrhoea in Prostate and Rectal Cancer

Keywords

Acute radiation-induced diarrhoea; Curative EBRT; Prostate cancer; Rectal cancer

Outcome Measures

Primary Outcomes (1)

• Frequency and classification of radiation-induced diarrhrea in patients with prostate and rectal cancer during curative external radiotherapy

  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.

  1 June 2022 - 31 December 2023

Study Arms (1)

Prostate and rectal cancer patients

Curative EBRT

Other: No intervention

Interventions

No intervention OTHER

No intervention

Prostate and rectal cancer patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with curative EBRT for prostate or rectal cancer

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, North Region, 9200, Denmark

Location

Related Publications (22)

• McBride 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 BACKGROUND

• Andreyev 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 BACKGROUND

• Muls 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 BACKGROUND

• Morris 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 BACKGROUND

• Stacey 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 BACKGROUND

• Andreyev 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 BACKGROUND

• Khalid 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.

  PMID: 16580497 BACKGROUND

• Barnett GC, De Meerleer G, Gulliford SL, Sydes MR, Elliott RM, Dearnaley DP. The impact of clinical factors on the development of late radiation toxicity: results from the Medical Research Council RT01 trial (ISRCTN47772397). Clin Oncol (R Coll Radiol). 2011 Nov;23(9):613-24. doi: 10.1016/j.clon.2011.03.001. Epub 2011 Apr 5.

  PMID: 21470834 BACKGROUND

• O'Brien PC, Franklin CI, Poulsen MG, Joseph DJ, Spry NS, Denham JW. Acute symptoms, not rectally administered sucralfate, predict for late radiation proctitis: longer term follow-up of a phase III trial--Trans-Tasman Radiation Oncology Group. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):442-9. doi: 10.1016/s0360-3016(02)02931-0.

  PMID: 12243820 BACKGROUND

• Lawrie TA, Green JT, Beresford M, Wedlake L, Burden S, Davidson SE, Lal S, Henson CC, Andreyev HJN. Interventions to reduce acute and late adverse gastrointestinal effects of pelvic radiotherapy for primary pelvic cancers. Cochrane Database Syst Rev. 2018 Jan 23;1(1):CD012529. doi: 10.1002/14651858.CD012529.pub2.

  PMID: 29360138 BACKGROUND

• Murphy J, Stacey D, Crook J, Thompson B, Panetta D. Testing control of radiation-induced diarrhea with a psyllium bulking agent: a pilot study. Can Oncol Nurs J. 2000 Summer;10(3):96-100. doi: 10.5737/1181912x10396100.

  PMID: 11894282 BACKGROUND

• Itoh Y, Mizuno M, Ikeda M, Nakahara R, Kubota S, Ito J, Okada T, Kawamura M, Kikkawa F, Naganawa S. A Randomized, Double-Blind Pilot Trial of Hydrolyzed Rice Bran versus Placebo for Radioprotective Effect on Acute Gastroenteritis Secondary to Chemoradiotherapy in Patients with Cervical Cancer. Evid Based Complement Alternat Med. 2015;2015:974390. doi: 10.1155/2015/974390. Epub 2015 Nov 26.

  PMID: 26693248 BACKGROUND

• Wedlake LJ, McGough C, Shaw C, Klopper T, Thomas K, Lalji A, Dearnaley DP, Blake P, Tait D, Khoo VS, Andreyev HJ. Clinical trial: Efficacy of a low or modified fat diet for the prevention of gastrointestinal toxicity in patients receiving radiotherapy treatment for pelvic malignancies. J Hum Nutr Diet. 2012 Jun;25(3):247-59. doi: 10.1111/j.1365-277X.2012.01248.x. Epub 2012 Apr 20.

  PMID: 22515941 BACKGROUND

• Stryker JA, Bartholomew M. Failure of lactose-restricted diets to prevent radiation-induced diarrhea in patients undergoing whole pelvis irradiation. Int J Radiat Oncol Biol Phys. 1986 May;12(5):789-92. doi: 10.1016/0360-3016(86)90037-4.

  PMID: 3086261 BACKGROUND

• Ravasco P, Monteiro-Grillo I, Vidal PM, Camilo ME. Dietary counseling improves patient outcomes: a prospective, randomized, controlled trial in colorectal cancer patients undergoing radiotherapy. J Clin Oncol. 2005 Mar 1;23(7):1431-8. doi: 10.1200/JCO.2005.02.054. Epub 2005 Jan 31.

  PMID: 15684319 BACKGROUND

• Kozelsky TF, Meyers GE, Sloan JA, Shanahan TG, Dick SJ, Moore RL, Engeler GP, Frank AR, McKone TK, Urias RE, Pilepich MV, Novotny PJ, Martenson JA; North Central Cancer Treatment Group. Phase III double-blind study of glutamine versus placebo for the prevention of acute diarrhea in patients receiving pelvic radiation therapy. J Clin Oncol. 2003 May 1;21(9):1669-74. doi: 10.1200/JCO.2003.05.060.

  PMID: 12721240 BACKGROUND

• Rotovnik Kozjek N, Kompan L, Soeters P, Oblak I, Mlakar Mastnak D, Mozina B, Zadnik V, Anderluh F, Velenik V. Oral glutamine supplementation during preoperative radiochemotherapy in patients with rectal cancer: a randomised double blinded, placebo controlled pilot study. Clin Nutr. 2011 Oct;30(5):567-70. doi: 10.1016/j.clnu.2011.06.003. Epub 2011 Jul 5.

  PMID: 21733605 BACKGROUND

• Vidal-Casariego A, Calleja-Fernandez A, de Urbina-Gonzalez JJ, Cano-Rodriguez I, Cordido F, Ballesteros-Pomar MD. Efficacy of glutamine in the prevention of acute radiation enteritis: a randomized controlled trial. JPEN J Parenter Enteral Nutr. 2014 Feb;38(2):205-13. doi: 10.1177/0148607113478191. Epub 2013 Mar 7.

  PMID: 23471208 BACKGROUND

• Kavanagh BD, Pan CC, Dawson LA, Das SK, Li XA, Ten Haken RK, Miften M. Radiation dose-volume effects in the stomach and small bowel. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S101-7. doi: 10.1016/j.ijrobp.2009.05.071.

  PMID: 20171503 BACKGROUND

• Abbott J, Teleni L, McKavanagh D, Watson J, McCarthy AL, Isenring E. Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF) is a valid screening tool in chemotherapy outpatients. Support Care Cancer. 2016 Sep;24(9):3883-7. doi: 10.1007/s00520-016-3196-0. Epub 2016 Apr 19.

  PMID: 27095352 BACKGROUND

• Jager-Wittenaar H, Ottery FD. Assessing nutritional status in cancer: role of the Patient-Generated Subjective Global Assessment. Curr Opin Clin Nutr Metab Care. 2017 Sep;20(5):322-329. doi: 10.1097/MCO.0000000000000389.

  PMID: 28562490 BACKGROUND

• Ottery FD. Definition of standardized nutritional assessment and interventional pathways in oncology. Nutrition. 1996 Jan;12(1 Suppl):S15-9. doi: 10.1016/0899-9007(96)90011-8.

  PMID: 8850213 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Faecal samples and blood during RID in a sub cohort of patients

MeSH Terms

Conditions

Rectal Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 13, 2023
• Study Start: June 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 24, 2025

Record last verified: 2024-02

Locations

DK (1)