CClinicalTrials.gg
CompletedNCT03260647MAMBOUpdated Jun 22, 2025

Risk Stratified Multidisciplinary Ambulatory Management of Malignant Bowel Obstruction in Gynecological Cancers

An observational study in Gynecologic Cancer, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-06-22.

Sponsored by University Health Network, Toronto · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
96
Ages
18 Years to 100 Years
Sex
Female
01

Study summary

Management of Malignant Bowel Obstruction (MBO) in Patients with Advanced Gynecological Cancers

Read the detailed description

Guidelines for the management of patients with Malignant Bowel Obstruction(MBO) are not available and as such, there remains an urgent need for a collaborative approach to streamline patient care and optimize use of hospital resources. This study will focus on management of MBO in advanced gynecological cancers.If patients with MBO can be effectively managed in an ambulatory setting, this may improve quality and consistency of patient care, and help reduce volume and duration of bed occupancy.

02

Conditions studied

  • Gynecologic Cancer
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with gynecological cancer and at risk or presently having Malignant bowel obstruction (MBO)

Inclusion criteria

Histologically and /or cytologically confirmed gynecological cancer, including ovarian, fallopian tube, endometrial, cervical or primary peritoneal cancer Deemed to be at risk of developing or have a clinical diagnosis of MBO as defined using the following criteria: clinical evidence of bowel obstruction (history/physical/radiological examination; and bowel obstruction beyond the ligament of Treitz.

Exclusion criteria

Exclusion Criteria:

There are no specified exclusion criteria for this study

04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
96 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherManagement algorithm for Malignant Bowel Obstruction

    a proposed management algorithm for MBO has been developed to provide a pathway that safeguards quality and continuity of care for patients under a multidisciplinary team. It will engage key-stakeholders and foster an inter-professional approach. It incorporates an in-patient management algorithm and a novel nursing-led ambulatory management algorithm to supplement patient's medical management

05

What researchers measure

Primary outcomes

  1. Optimization of multidisciplinary care

    To optimize the multidisciplinary care management of MBO in patients with advanced gynecological cancer treated at University Health Network (UHN) which include in-patient and ambulatory management algorithm for MBO • Measured by a ratio of days alive and out of hospital compare to days in hospital within the first 60 days after diagnosis of MBO

    Time frame: 2 years

Secondary outcomes

  1. Evaluation of treatment outcomes

    To evaluate the treatment outcomes of patients with MBO * Measured by resolution of MBO and overall survival * Measured by transition through specific bowel management colour code system

    Time frame: 2 years

  2. Evaluation of impact of MBO management on hospital visits

    To evaluate the impact of MBO management on number of emergency room visits, hospital admission and number of days alive and outside of hospital within the first 168 days (6 months) after the diagnosis of MBO

    Time frame: 2 years

  3. Evaluation of impact of MBO management on patient reported outcomes

    To evaluate the impact of ambulatory MBO management on patient reported outcomes using the Distress Assessment \& Response Tool (DART)

    Time frame: 2 years

  4. To evaluate nutritional status of patients with MBO

    To evaluate the nutritional status of patients with MBO • Measured by monthly albumin and weight

    Time frame: 2 years

  5. Evaluation of clinico-pathological factors

    To evaluate the clinico-pathological factors that may predict benefit from palliative surgery, chemotherapy and total parenteral nutrition (TPN)

    Time frame: 2 years

  6. Improve patient understanding and awareness of MBO

    To improve patients' understanding and awareness of MBO with patient education material.

    Time frame: 2 years

  7. Determine percentage number of patient microbiome sample analyses completed

    To record the percentage of patients who agree to, and for whom sample collection and analysis is completed

    Time frame: 1.5 years

  8. Record changes in the sum and types of gut microbiome from baseline to study end

    Changes in the sum as well as types of microbiomes as recorded at baseline, initiation of total parenteral nutrition, incidence of an MBO and end of study are to be recorded

    Time frame: 1.5 years

  9. Evaluate cannabis use in patient population

    Assess for any relationship between cannabis use and MBO

    Time frame: 1.5 years

06

Study locations

1 site
  • Princess Margaret Cancer Centre
    Toronto, Ontario, Canada
07

References and documents

Publications

  • Tran E, Spiceland C, Sandhu NP, Jatoi A. Malignant Bowel Obstruction in Patients With Recurrent Ovarian Cancer. Am J Hosp Palliat Care. 2016 Apr;33(3):272-5. doi: 10.1177/1049909114566225. Epub 2014 Dec 31. PubMed 25552305 ↗
  • Mooney SJ, Winner M, Hershman DL, Wright JD, Feingold DL, Allendorf JD, Neugut AI. Bowel obstruction in elderly ovarian cancer patients: a population-based study. Gynecol Oncol. 2013 Apr;129(1):107-12. doi: 10.1016/j.ygyno.2012.12.028. Epub 2012 Dec 26. PubMed 23274561 ↗
  • Sartori E, Chiudinelli F, Pasinetti B, Maggino T. Bowel obstruction and survival in patients with advanced ovarian cancer: analysis of prognostic variables. Int J Gynecol Cancer. 2009 Jan;19(1):54-7. doi: 10.1111/IGC.0b013e318198ff4b. No abstract available. PubMed 19258942 ↗
  • Jayson GC, Kohn EC, Kitchener HC, Ledermann JA. Ovarian cancer. Lancet. 2014 Oct 11;384(9951):1376-88. doi: 10.1016/S0140-6736(13)62146-7. Epub 2014 Apr 21. PubMed 24767708 ↗
  • Martin-Lorente C, Mackay H, Lafromboise L, et al: Retrospective review of malignant bowel obstruction (MBO) outcomes in patients with epithelial ovarian carcinoma (EOC), International Journal of Gynecological Cancer, 2015, pp 1434-1435
  • Anthony T, Baron T, Mercadante S, Green S, Chi D, Cunningham J, Herbst A, Smart E, Krouse RS. Report of the clinical protocol committee: development of randomized trials for malignant bowel obstruction. J Pain Symptom Manage. 2007 Jul;34(1 Suppl):S49-59. doi: 10.1016/j.jpainsymman.2007.04.011. Epub 2007 Jun 4. PubMed 17544243 ↗
  • Ripamonti C, Twycross R, Baines M, Bozzetti F, Capri S, De Conno F, Gemlo B, Hunt TM, Krebs HB, Mercadante S, Schaerer R, Wilkinson P; Working Group of the European Association for Palliative Care. Clinical-practice recommendations for the management of bowel obstruction in patients with end-stage cancer. Support Care Cancer. 2001 Jun;9(4):223-33. doi: 10.1007/s005200000198. PubMed 11430417 ↗
  • Tuca A, Guell E, Martinez-Losada E, Codorniu N. Malignant bowel obstruction in advanced cancer patients: epidemiology, management, and factors influencing spontaneous resolution. Cancer Manag Res. 2012;4:159-69. doi: 10.2147/CMAR.S29297. Epub 2012 Jun 13. PubMed 22904637 ↗
  • Daniele A, Ferrero A, Fuso L, Mineccia M, Porcellana V, Vassallo D, Biglia N, Menato G. Palliative care in patients with ovarian cancer and bowel obstruction. Support Care Cancer. 2015 Nov;23(11):3157-63. doi: 10.1007/s00520-015-2694-9. Epub 2015 Mar 25. PubMed 25805450 ↗
  • Ripamonti CI, Easson AM, Gerdes H. Management of malignant bowel obstruction. Eur J Cancer. 2008 May;44(8):1105-15. doi: 10.1016/j.ejca.2008.02.028. Epub 2008 Mar 21. PubMed 18359221 ↗
  • Cousins SE, Tempest E, Feuer DJ. Surgery for the resolution of symptoms in malignant bowel obstruction in advanced gynaecological and gastrointestinal cancer. Cochrane Database Syst Rev. 2016 Jan 4;2016(1):CD002764. doi: 10.1002/14651858.CD002764.pub2. PubMed 26727399 ↗
  • Feuer DJ, Broadley KE, Shepherd JH, Barton DP. Surgery for the resolution of symptoms in malignant bowel obstruction in advanced gynaecological and gastrointestinal cancer. Cochrane Database Syst Rev. 2000;(4):CD002764. doi: 10.1002/14651858.CD002764. PubMed 11034757 ↗
  • Furnes B, Svensen R, Helland H, Ovrebo K. Challenges and outcome of surgery for bowel obstruction in women with gynaecologic cancer. Int J Surg. 2016 Mar;27:158-164. doi: 10.1016/j.ijsu.2016.02.002. Epub 2016 Feb 4. PubMed 26853847 ↗
  • Levy M, Smith T, Alvarez-Perez A, Back A, Baker JN, Beck AC, Block S, Dalal S, Dans M, Fitch TR, Kapo J, Kutner JS, Kvale E, Misra S, Mitchell W, Portman DG, Sauer TM, Spiegel D, Sutton L, Szmuilowicz E, Taylor RM, Temel J, Tickoo R, Urba SG, Weinstein E, Zachariah F, Bergman MA, Scavone JL. Palliative Care Version 1.2016. J Natl Compr Canc Netw. 2016 Jan;14(1):82-113. doi: 10.6004/jnccn.2016.0009. PubMed 26733557 ↗
  • Kolomainen DF, Daponte A, Barton DP, Pennert K, Ind TE, Bridges JE, Shepherd JH, Gore ME, Kaye SB, Riley J. Outcomes of surgical management of bowel obstruction in relapsed epithelial ovarian cancer (EOC). Gynecol Oncol. 2012 Apr;125(1):31-6. doi: 10.1016/j.ygyno.2011.11.007. Epub 2011 Nov 12. PubMed 22082991 ↗
  • Mangili G, Aletti G, Frigerio L, Franchi M, Panacci N, Vigano R, DE Marzi P, Zanetto F, Ferrari A. Palliative care for intestinal obstruction in recurrent ovarian cancer: a multivariate analysis. Int J Gynecol Cancer. 2005 Sep-Oct;15(5):830-5. doi: 10.1111/j.1525-1438.2005.00144.x. PubMed 16174232 ↗
  • Goto T, Takano M, Aoyama T, Miyamoto M, Watanabe A, Kato M, Sasaki N, Hirata J, Sasa H, Furuya K. Outcomes of palliative bowel surgery for malignant bowel obstruction in patients with gynecological malignancy. Oncol Lett. 2012 Nov;4(5):883-888. doi: 10.3892/ol.2012.835. Epub 2012 Jul 30. PubMed 23162616 ↗
  • Kucukmetin A, Naik R, Galaal K, Bryant A, Dickinson HO. Palliative surgery versus medical management for bowel obstruction in ovarian cancer. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD007792. doi: 10.1002/14651858.CD007792.pub2. PubMed 20614464 ↗
  • Bryan DN, Radbod R, Berek JS. An analysis of surgical versus chemotherapeutic intervention for the management of intestinal obstruction in advanced ovarian cancer. Int J Gynecol Cancer. 2006 Jan-Feb;16(1):125-34. doi: 10.1111/j.1525-1438.2006.00283.x. PubMed 16445622 ↗
  • Diver E, O'Connor O, Garrett L, Boruta D, Goodman A, Del Carmen M, Schorge J, Mueller P, Growdon W. Modest benefit of total parenteral nutrition and chemotherapy after venting gastrostomy tube placement. Gynecol Oncol. 2013 May;129(2):332-5. doi: 10.1016/j.ygyno.2013.02.002. Epub 2013 Feb 8. PubMed 23402902 ↗
  • Chouhan J, Gupta R, Ensor J, Raghav K, Fogelman D, Wolff RA, Fisch M, Overman MJ. Retrospective analysis of systemic chemotherapy and total parenteral nutrition for the treatment of malignant small bowel obstruction. Cancer Med. 2016 Feb;5(2):239-47. doi: 10.1002/cam4.587. Epub 2015 Dec 29. PubMed 26714799 ↗
  • Abu-Rustum NR, Barakat RR, Venkatraman E, Spriggs D. Chemotherapy and total parenteral nutrition for advanced ovarian cancer with bowel obstruction. Gynecol Oncol. 1997 Mar;64(3):493-5. doi: 10.1006/gyno.1996.4605. PubMed 9062158 ↗
  • Li M, Macedo A, Crawford S, Bagha S, Leung YW, Zimmermann C, Fitzgerald B, Wyatt M, Stuart-McEwan T, Rodin G. Easier Said Than Done: Keys to Successful Implementation of the Distress Assessment and Response Tool (DART) Program. J Oncol Pract. 2016 May;12(5):e513-26. doi: 10.1200/JOP.2015.010066. Epub 2016 Apr 5. PubMed 27048610 ↗
  • Brard L, Weitzen S, Strubel-Lagan SL, Swamy N, Gordinier ME, Moore RG, Granai CO. The effect of total parenteral nutrition on the survival of terminally ill ovarian cancer patients. Gynecol Oncol. 2006 Oct;103(1):176-80. doi: 10.1016/j.ygyno.2006.02.013. Epub 2006 Mar 27. PubMed 16564074 ↗
  • Cusimano MC, Sajewycz K, Nelson M, Jivraj N, Lee YC, Bowering V, Oza A, Lheureux S, Ferguson SE. Supported self-management as a model for end-of-life care in the setting of malignant bowel obstruction: A qualitative study. Gynecol Oncol. 2020 Jun;157(3):745-753. doi: 10.1016/j.ygyno.2020.03.009. Epub 2020 Mar 23. PubMed 32217004 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03260647
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Aug 24, 2017
Start date
Aug 4, 2017
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Jun 22, 2025

Study contacts

Stephanie Lheureux
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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