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Prevention of Opioid-induced Constipation in Patients With Advanced Cancer

Study acronym: OMAMA
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 2025 → Jan 2027
Enrollment reduced 22% 330 → 258 participants
See other at-risk trials from Amsterdam UMC, location VUmc

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Dec 2025 to Jan 2027 Show 8 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Enrollment reduced: 330 → 258 participants
    • Study completion pushed from Dec 2025 to Jun 2027
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Site details revised at 3 of 13 sites
    • Collaborators revised (15)
    • Publications: details revised at 28 of 28 entries
  2. Notable Primary completion date: Aug 2024 to Dec 2025
    • Study completion date: Oct 2024 to Dec 2025
    • Collaborators: 12 to 15
    v12
  3. Minor Site details revised at 3 of 13 sitesv11
  4. Notable Phase: Phase 3 to Phase 4
    • Study sites: 11 to 13
    • Collaborators: 10 to 12
    • Study title shortened, about 4 words
    v10
  5. Minor Site details revised at 3 of 11 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Study sites: 10 to 11
    • Collaborators: 9 to 10
    • Study title expanded, about 4 words
    v8
  2. Minor Start date changed from estimate of Nov 2022 to Dec 2, 2022v7
  3. Minor Start date: Oct 27, 2022 to Nov 2022
    • Site details revised at 1 of 10 sites
    v6
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2022 to Oct 27, 2022
    • Site details revised at 10 of 10 sites
    v5
  5. Minor Trial status: Recruiting to Not Yet Recruiting
    • Site details revised at 10 of 10 sites
    v4
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 10 of 10 sites
    • Collaborators revised (9)
    v3
  7. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
More than 70% of patients with cancer in the palliative phase have pain that often requires treatment with opioids (morphine-like agents). Constipation occurs in 59% of patients treated with opioids. Opioid-induced constipation (OIC) has consequences that range from daily discomfort with social insecurity and disability to intestinal obstruction. It leads to limitations in self-management, a reduced quality of life and a risk of the need for more care. In the guideline "Diagnosis and treatment of pain in patients with cancer" it is recommended to start preventively with an osmotic laxative such as macrogol/electrolytes or magnesium hydroxide when starting opioids. Macrogol/electrolytes has been proven to be effective for OIC, but is sometimes perceived by patients as unpleasant due to its taste. Magnesium hydroxide, which is less commonly prescribed for OIC, has a neutral taste. Although it is mentioned in the guideline, it is not studied for the treatment of OIC and also not officially registered for this. To support the advice of the guideline and to prove that a choice is possible, it is important to investigate whether there are differences in effectiveness and/or side effects between macrogol/electrolytes and magnesium hydroxide in the prevention of OIC. The aim of this study is to compare macrogol/electrolytes with magnesium hydroxide in the prevention of opioid-induced constipation in patients with cancer in the palliative (incurable) phase, who start opioids because of pain. The choice of laxative is determined by drawing lots (randomisation). After two weeks, its effect will be assessed and will be presented as the percentage of patients who have not developed constipation after starting opioids. If the laxative, as assigned by lot, is described as satisfactory by the patient, the patient can continue with the drug that the patient used, after the study through regular prescription. The investigators will ask the patients in the study about their satisfaction with the laxative used, any side effects and the degree of pain. Furthermore, the appeal to care for possible constipation will be examined. Because the best attainable quality of life in the palliative phase is the objective of all care, the investigators will also measure this perceived quality with a questionnaire in this study. The results of this study will lead to the best achievable prevention of opioid constipation in patients with cancer in the palliative phase.
Trial Details
NCT Number NCT05216328
Lead Sponsor Amsterdam UMC, location VUmc
Collaborators: Leiden University Medical Center, University Medical Center Groningen, Radboud University Medical Center, Erasmus Medical Center, Spaarne Gasthuis, Rijnstate Hospital, Jeroen Bosch Ziekenhuis, Flevoziekenhuis, Martini Hospital Groningen, Haaglanden Medical Centre, UMC Utrecht, Groene Hart Ziekenhuis, Bernhoven Hospital, Isala, Antoni van Leeuwenhoek Hospital
Conditions
(from sponsor)
Constipation, Opioid-Induced
Related terms Cancer Pain, Neoplasms, Opioid-Induced Constipation
Enrollment 258 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov