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Study on Preventing Opioid-Induced Constipation in Advanced Cancer Patients Using Magnesium Hydroxide and Macrogol 3350 Combination

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on preventing opioid-induced constipation in patients with advanced cancer. Opioids are strong pain-relieving medications often used by cancer patients, but they can cause constipation, which is a common side effect. The study will compare two treatments: Movicolon Naturel, an oral solution containing macrogol 3350 and electrolytes like sodium hydrogen carbonate, potassium chloride, and sodium chloride, and Magnesiumhydroxide Teva, a chewable tablet containing magnesium hydroxide.

The purpose of the study is to determine if magnesium hydroxide is as effective as macrogol/electrolytes in preventing constipation caused by opioids. Participants will be patients with advanced cancer who are starting opioid treatment for pain management. The study will last for 14 days, during which the effectiveness of the treatments will be assessed based on the absence of constipation.

Throughout the study, participants will be monitored for changes in bowel function, quality of life, and any side effects from the laxatives. The study will also evaluate the cost-effectiveness of the treatments and patient satisfaction. The goal is to find a reliable way to prevent constipation in patients who need opioids for pain relief, improving their overall comfort and quality of life.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must be patients with advanced cancer, aged 18 or older, starting with slow-release or transdermal opioids for pain, and able to complete a Dutch questionnaire.

  2. Step 2

    Beginning treatment

    The treatment involves taking medications to prevent constipation caused by opioids. Two types of medications are used: Movicolon Naturel 13.7 g, a powder for oral solution, and Magnesiumhydroxide Teva 724 mg, chewable tablets.

    The medications are taken orally. The exact dosage and frequency will be provided by the healthcare team.

  3. Step 3

    Treatment duration

    The treatment lasts for 14 days. During this period, the effectiveness of the medications in preventing constipation is monitored.

  4. Step 4

    Monitoring and assessment

    Throughout the trial, the Bowel Function Index is used to measure bowel function. A score of less than 30 indicates no constipation.

    Other assessments include changes in bowel function score, quality of life, cancer pain score, side effects of laxatives, and patient satisfaction with the laxative.

  5. Step 5

    Completion of the trial

    At the end of the 14-day period, a final assessment is conducted to evaluate the primary endpoint, which is the percentage of patients without constipation.

    Secondary endpoints such as quality of life and patient satisfaction are also evaluated.

Who can join the trial?

4 criteria

  • Patients must have advanced cancer.
  • Patients must be 18 years or older.
  • Patients must be starting treatment with slow release or transdermal opioids for pain.
    (Opioids are strong pain-relieving medications, and "slow release" means the medication is released slowly over time. "Transdermal" means the medication is given through a patch on the skin.)
  • Patients must be able to complete a Dutch questionnaire.

Who cannot join the trial?

4 criteria

  • Patients who do not have advanced cancer.
  • Patients who are not starting treatment with opioids for pain. Opioids are strong pain-relieving medications.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Magnesium Hydroxide

    is a medication used to help prevent constipation. It works by drawing water into the intestines, which helps to soften the stool and make it easier to pass. In this clinical trial, it is being tested to see if it can prevent constipation in patients with advanced cancer who are taking opioids for pain management.

  • Macrogol/Electrolytes

    is a combination therapy used to treat constipation. Macrogol, also known as polyethylene glycol, helps to retain water in the stool, making it softer and easier to pass. The electrolytes help to maintain the body's normal balance of salts and minerals. In this trial, it is being used as a comparison to see if it is more or less effective than magnesium hydroxide in preventing constipation in patients taking opioids for cancer pain.

What is already known about the treatment

  • Magnesium Hydroxide

    Magnesium hydroxide is typically administered orally in the form of a liquid or tablet. It is currently being studied in clinical trials for its effectiveness in preventing constipation caused by opioid use in patients with advanced cancer. The main therapeutic indication is to prevent opioid-induced constipation. At the molecular level, magnesium hydroxide works by drawing water into the intestines, which helps to soften stools and promote bowel movements. It is classified as an osmotic laxative.

  • Macrogol/Electrolytes

    Macrogol with electrolytes is usually taken orally as a powder mixed with water. It is being evaluated in clinical trials for its role in preventing constipation in cancer patients who are taking opioids for pain management. The primary therapeutic use is to prevent constipation due to opioid use. Macrogol works by retaining water in the stool, which increases stool volume and triggers bowel movements. It is classified as an osmotic laxative.

Investigated diseases

Advanced Cancer – Advanced cancer refers to cancer that has spread from its original site to other parts of the body. This stage of cancer is characterized by the growth of tumors in multiple locations, which can affect various organs and tissues. As the disease progresses, it may lead to symptoms such as pain, fatigue, and weight loss. The spread of cancer cells can disrupt normal bodily functions and lead to complications. The progression of advanced cancer varies depending on the type of cancer and the organs involved. It often requires comprehensive management to address symptoms and maintain quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509462-38-00Protocol code08440012010002Estimated enrolment250 patientsSponsorAmsterdam UMC Stichting

sourced from the EU Clinical Trials Register and site verification

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