Preventing constipation caused by opioids in advanced cancer patients
OMAMA-study - Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
PHASE4 · Amsterdam UMC, location VUmc · NCT05216328
This study is testing whether magnesium hydroxide can help prevent constipation caused by opioid pain medications in advanced cancer patients better than a standard treatment.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc (other) |
| Locations | 13 sites (Almere Stad, Flevoland and 12 other locations) |
| Trial ID | NCT05216328 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of magnesium hydroxide compared to macrogol/electrolytes in preventing opioid-induced constipation (OIC) in patients with advanced cancer who are starting opioid treatment for pain management. Given that OIC affects a significant portion of cancer patients, the study will assess the tolerability and efficacy of these treatments in improving patient quality of life. Participants will be required to complete a questionnaire in Dutch to assess their symptoms and treatment outcomes. The study is designed to provide insights into a less commonly used laxative option that may be more acceptable to patients due to its neutral taste.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with metastatic cancer who are beginning treatment with slow-release or transdermal opioids.
Not a fit: Patients with contraindications for laxatives, those using laxatives in the past four weeks, or those with severely impaired renal function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more tolerable treatment option for preventing constipation in patients undergoing opioid therapy for cancer pain.
How similar studies have performed: While macrogol/electrolytes has been proven effective for OIC, magnesium hydroxide has not been extensively studied for this purpose, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Patients with metastatic cancer (≥18 years); * Starting with slow release or transdermal opioids for pain; * Able to complete a Dutch questionnaire. Previous treatment with opioids is allowed, if discontinued more than 4 weeks ago. Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Patients with contra-indications for laxatives * Use of laxatives during the last four weeks * Severely impaired renal function (serum creatinine \>180 umol/l) * Estimated life expectancy \<3 months
Where this trial is running
Almere Stad, Flevoland and 12 other locations
- Flevoziekenhuis — Almere Stad, Flevoland, Netherlands (RECRUITING)
- Rijnstate Ziekenhuis — Arnhem, Gelderland, Netherlands (RECRUITING)
- Radboud university Medical center Nijmegen — Nijmegen, Gelderland, Netherlands (RECRUITING)
- Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, North Brabant, Netherlands (RECRUITING)
- Amsterdam UMC, location VUmc — Amsterdam, North Holland, Netherlands (RECRUITING)
- Spaarne Gasthuis — Hoofddorp, North Holland, Netherlands (RECRUITING)
- Groene Hart Hospital — Gouda, South Holland, Netherlands (RECRUITING)
- Leiden University Medical Center — Leiden, South Holland, Netherlands (RECRUITING)
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (RECRUITING)
- Haaglanden Medical Centre — The Hague, South Holland, Netherlands (RECRUITING)
- University Medical Center Groningen — Groningen, Netherlands (RECRUITING)
- Martini Hospital Groningen — Groningen, Netherlands (RECRUITING)
- University Medical Center Utrecht — Utrecht, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Lia van Zuylen, Prof.dr. — Amsterdam UMC, location VUmc
- Study coordinator: Kay Kistemaker, MSc/MD
- Email: k.kistemaker@amsterdamumc.nl
- Phone: +31 6 50087799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Constipation, Opioid-Induced, Cancer, Palliative care, Cancer pain, Opioid-Induced Constipation, macrogol/electrolytes, magnesium hydroxide