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AzTrials

Gynecologic CancerMAMBONCT03260647

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

An observational study of Gynecologic Cancer, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Management of Malignant Bowel Obstruction (MBO) in Patients with Advanced Gynecological Cancers Read more about this study

Who is it for?
Ages 18 to 100 years, women only
Conditions the study is for
Gynecologic Cancer
What is being tested?
Management algorithm for Malignant Bowel Obstruction
How many people
96 participants
Where
1 siteCanada
Study dates
4 Aug 2017to 31 Dec 2024
Phase
Observational
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 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • There are no specified exclusion criteria for this study

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario

Other trials in Canada

About this study

Official title: Risk Stratified Multidisciplinary Ambulatory Management of Malignant Bowel Obstruction (MAMBO) Program for Women With Advanced Gynecological Cancers

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.

Being tested
Management algorithm for Malignant Bowel Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Management algorithm for Malignant Bowel ObstructionOther

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (9)

  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

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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)

    Measured: 2 years

  6. Improve patient understanding and awareness of MBO

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

    Measured: 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

    Measured: 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

    Measured: 1.5 years

  9. Evaluate cannabis use in patient population

    Assess for any relationship between cannabis use and MBO

    Measured: 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2017
  2. Study start4 Aug 2017
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03260647
Sponsor's protocol ID
MAMBO
Acronym
MAMBO
Status last verified
Jun 2025
First submitted
21 Aug 2017
Last updated
22 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Gynecologic Cancer, run by University Health Network, Toronto at 1 site in Canada.

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 1 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 22 Jun 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Optimization of multidisciplinary care (time frame: 2 years). 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 NCT03260647, which also lists 26 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 22 Jun 2025.

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