Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

PARASTOP – Paracetamol with Strong Opioids. A randomized, double-blind, parallel-group non-inferiority phase III withdrawal trial of paracetamol versus placebo in conjunction with opioids for moderate to severe cancer-related pain

This research study, called PARASTOP, is investigating the use of paracetamol alongside strong pain relief medicines (opioids) for people experiencing moderate to severe pain from cancer that has spread. The main goal is to see if taking paracetamol tablets (1 gram) with your usual strong pain relief works as well as, or even better than, taking a dummy pill (placebo) with your strong pain relief. Researchers want to know if adding paracetamol can help manage pain without increasing the amount of opioids needed or causing more side effects. This study is for adults over 18, of any gender, who have metastatic cancer disease.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Oslo University Hospital HF

Enrolment target

179

Start

29 Oct 2024

Metastatic cancer disease

What is this study about?

This study, called PARASTOP, is exploring ways to manage pain caused by cancer that has spread to other parts of the body. We know that strong pain relief medicines, called opioids, are often used for this kind of pain. However, doctors are always looking for ways to improve pain control and potentially reduce side effects that can come with these strong medicines.

This research wants to find out if adding a common painkiller like paracetamol to your strong opioid medicine makes a difference. They will compare a group of people who take paracetamol with their opioid to another group who take a dummy pill (called a placebo) with their opioid. A dummy pill looks exactly like the real medicine but contains no active drug, and is used to make sure that any observed effects are due to the actual medicine being tested and not just someone expecting to feel better.

Ultimately, this study aims to see if paracetamol can be a helpful addition to your pain management plan, potentially improving your pain control and overall comfort. Finding effective ways to manage pain is very important for people living with advanced cancer.

Key takeaways

Checks if paracetamol helps strong pain relief for cancer pain.
Compares paracetamol to a dummy pill (placebo).
For adults (18+) with cancer that has spread.
Aims to improve pain control and reduce side effects.
You won't know if you're taking paracetamol or the dummy pill.

Who may be eligible?

To take part in this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

The main requirement for joining is that you have cancer that has spread to other parts of your body, also known as metastatic cancer.

Beyond these basic conditions, your doctors and the study team will check other health details to make sure the study is a safe and suitable option for you. They will explain everything clearly during the screening process.

Quick self-check

Are you 18 years old or older?
Do you have cancer that has spread to other parts of your body (metastatic cancer)?
Do you experience moderate to severe pain because of your cancer?
Are you willing to take other strong pain relief medicines as part of your treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be given either paracetamol tablets (1 gram) or dummy tablets to take alongside your strong pain relief medicine. Neither you nor your study doctor would know which one you are taking – this is called a 'double-blind' study and helps make the results fair.

You would regularly be asked about your pain levels, such as how intense your pain is on average. You would also be asked about any side effects you experience, especially those related to your pain relief medicines. Researchers will also keep track of how much strong pain relief you are using.

There will be several visits to the clinic or hospital, during which assessments will be carried out. The study team will provide a detailed schedule, but generally, participants will be involved for a specific period to monitor their pain and medicine use.

Potential risks and benefits

Taking part in a study is a very personal choice. A potential benefit could be improved pain control if the paracetamol helps your strong pain relief work better. You would also be contributing to medical knowledge that could help others with cancer pain in the future. However, like all medicines, paracetamol can have side effects, although these are usually mild. The dummy pill has no active drug, but it's important to report anything you feel. The study team will explain all known potential risks and side effects in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Norway

Common questions

What is 'metastatic cancer disease'?

This means cancer that has spread from where it started to other parts of your body.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers see if the real medicine is truly effective.

Why don't I know if I'm getting paracetamol or a dummy pill?

This is to make the study fair. If you or your doctor knew, it might change how you feel or how your doctor assesses your pain, which could affect the results.

What kind of pain is this study for?

This study is for people experiencing moderate to severe pain related to their cancer.

Will my regular pain medication be stopped if I join?

No, this study is about adding paracetamol or a dummy pill to your current strong pain relief. Your existing pain management plan will be continued.