Study of methadone and morphine combination for pain relief in patients with bone metastases from cancer

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What is this study about?

This study focuses on patients with metastatic bone pain, which occurs when cancer spreads to the bones. The research examines whether adding methadone to existing pain medications can provide better pain relief compared to adding morphine sulfate. Both medications are strong pain relievers that belong to a group of medicines called opioids.

The study aims to determine if methadone, when combined with current pain medication, is more effective at reducing bone pain than morphine in cancer patients. During the study, participants will receive either methadone or morphine capsules in addition to their regular pain medication. The treatment period lasts for three weeks, during which patients will need to take the study medication orally.

Throughout the study period, patients will record their pain levels and any side effects they experience. The study will also look at how the medications affect daily activities and overall quality of life. Both medications will be given in capsule form, with carefully controlled dosing to ensure patient safety.

1 Initial pain assessment

Your current pain level will be measured using a scale from 0 to 10

You will need to have a pain score of 5 or higher to continue in the study

You must already be taking strong pain medication (opioids) for at least 7 days

2 Starting study medication

You will receive either methadone or morphine capsules to take by mouth

The medication will be added to your current pain treatment

You will not know which medication you are receiving during the study

3 First week monitoring

You will record your pain levels daily using a 0-10 scale

On days 5, 6, and 7, your pain scores will be carefully monitored

You will report any side effects on day 7 using a special diary

4 Second week assessment

Continue taking the study medication as directed

Record your pain levels daily

Complete a quality of life questionnaire on day 14

Report any side effects on day 14

5 Final assessment

On day 21, you will have a final evaluation of your pain levels

Complete final quality of life questionnaires

Report any final side effects

Your daily pain medication dose will be compared to your starting dose

Who Can Join the Study?

  • Must have bone pain due to cancer spread with an average pain score of 5 or higher on a 0-10 scale
  • Must be currently using strong pain medications (opioids) at a stable dose for at least 7 days. The minimum daily dose should be equivalent to:
    • 60 mg of morphine, or
    • 40 mg of oxycodone, or
    • 25 micrograms per hour of fentanyl patch, or
    • 12 mg of hydromorphone
  • Must be 18 years of age or older
  • Women who can become pregnant must use effective birth control methods during the study period
  • Both men and women can participate in the study

Who Cannot Join the Study?

  • Known allergic reactions or severe sensitivity to morphine, methadone, or similar pain medications
  • Severe liver problems that affect the body’s ability to process medications
  • Severe kidney dysfunction that could impact drug metabolism
  • Respiratory problems such as severe asthma or breathing difficulties
  • History of substance abuse or addiction to pain medications
  • Patients taking certain medications that could interact with study drugs (such as certain antidepressants or heart medications)
  • Pregnancy or breastfeeding
  • Participation in other clinical trials within the past 30 days
  • Unable to follow study instructions or attend scheduled visits
  • Mental health conditions that could affect the ability to provide reliable pain assessments
  • Uncontrolled high blood pressure or serious heart conditions
  • Brain metastases (cancer spread to the brain) that are untreated or unstable
  • Life expectancy less than 3 months

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Amphia Hospital Breda The Netherlands
Maastro Maastricht The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
Reinier de Graaf Groep Delft The Netherlands
Oxmf Lzaem Vcghmqk Glxdcqea Amsterdam The Netherlands
Alekxythi Uua Amsterdam The Netherlands
Evxxgpm Ubjqykgalmrh Mjvvidb Cqbabbd Rzjkcccls (yxbtrbb Mqc Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.01.2026

Trial locations

Methadone is a strong pain medication belonging to the opioid family. In this trial, it is used as an additional pain reliever alongside other opioid medications that patients are already taking. It works by binding to specific receptors in the brain to help control severe pain, particularly in patients with bone pain caused by cancer that has spread.

Morphine is a powerful opioid pain medication used to treat severe pain. It is one of the most commonly used medications for managing cancer-related pain. It works by changing how the body senses and responds to pain signals.

Both medications are being studied to determine which one is more effective at reducing pain when added to existing pain treatment plans for patients with bone pain from metastatic cancer.

Investigated diseases:

Bone Metastasis – A condition where cancer cells spread from their original location to the bones, forming new tumors. These cancer cells typically travel through the bloodstream or lymphatic system to settle in bone tissue. The condition often affects multiple bones simultaneously, particularly the spine, pelvis, ribs, skull, and long bones of the arms and legs. Bone metastasis can cause the affected bones to weaken and become more susceptible to structural changes. The condition commonly leads to pain that may start gradually and become more persistent over time.

Cancer Pain – A complex physical sensation that occurs as a direct or indirect result of cancer presence in the body. It can range from mild to severe and may be constant or intermittent. Pain can arise from the tumor itself pressing on bones, nerves, or organs, or from cancer spreading to other parts of the body. The sensation can vary in nature, presenting as sharp, dull, aching, burning, or pressure-like discomfort.

Trial ID:
2025-522710-22-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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