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

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What is this trial about?

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

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.

The research process

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

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

8 criteria

Must have bone pain due to cancer spread with an average pain score of 5 or higher on a 0-10 scale
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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 trial?

13 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Amphia Hospital
Breda, The Netherlands
Verified
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands

Trial locations

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Investigated drugs

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.

What is already known about the treatment

Methadone
An opioid medication administered orally or intravenously that acts as a potent pain reliever and is being studied as a co-analgesic for bone metastasis pain management. It works by binding to mu-opioid receptors in the central nervous system to reduce pain perception and provides additional benefits through NMDA receptor antagonism, making it potentially more effective for complex pain conditions. This long-acting synthetic opioid belongs to the class of full opioid agonists and is particularly interesting in cancer pain management due to its unique dual mechanism of action and long half-life.
Morphine
A natural opioid medication available in oral, injectable, and other formulations, serving as the gold standard for treating severe pain, including cancer-related bone pain. It works primarily by activating mu-opioid receptors throughout the body's pain pathways, effectively reducing pain sensation and emotional response to pain. As the prototype opioid analgesic, it belongs to the class of full opioid agonists and remains one of the most commonly used medications for managing severe cancer pain, particularly in advanced stages with bone metastases.

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.