Study on Paracetamol and Strong Opioids for Pain Relief in Patients with Metastatic Cancer

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What is this study about?

This clinical trial is focused on studying the effects of withdrawing paracetamol when used alongside strong opioids for managing pain related to metastatic cancer. Metastatic cancer is a type of cancer that has spread from its original site to other parts of the body. The trial aims to determine if stopping paracetamol affects pain control compared to continuing its use with opioids, which are strong pain-relieving medications.

Participants in the study will either continue taking paracetamol or switch to a placebo while still receiving their regular opioid treatment. The study will observe how this change impacts their pain levels and any side effects related to opioid use. The trial will last for a short period, and participants will take the medications in tablet form.

The main goal is to see if stopping paracetamol leads to worse pain control compared to keeping it in the treatment plan. This information will help doctors understand the best way to manage pain for patients with metastatic cancer who are already using strong opioids.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the paracetamol or the placebo.

You will continue to receive your regular strong opioids for cancer pain throughout the study.

2 medication administration

If you are assigned to the paracetamol group, you will take 1 gram of paracetamol in tablet form, three or four times a day, as you have been doing for at least the past five days.

If you are assigned to the placebo group, you will take a placebo tablet, which looks like the paracetamol tablet but does not contain any active medication, three or four times a day.

3 monitoring and reporting

Throughout the trial, you will be asked to report your average pain intensity. This will help assess the effectiveness of the treatment you are receiving.

You will also be asked to report any side effects you experience that may be related to the opioids you are taking.

4 completion of the trial

The trial will continue until the estimated end date of December 31, 2027, unless otherwise specified by the study team.

At the end of the trial, your opioid consumption will be evaluated, including both scheduled and on-demand use.

Who Can Join the Study?

Participant must be 18 years of age or older at the time of signing the informed consent.
Able to take the study drug or placebo in the form of tablets.
Capable of giving signed informed consent, which means you understand the study and agree to participate.
Participants should be under palliative care or reviewed by an oncology service. Palliative care is specialized medical care focused on providing relief from the symptoms and stress of a serious illness.
Diagnosis of metastatic cancer. This includes all incurable solid tumors in an advanced stage, either locally advanced or spread to other parts of the body. It also includes certain types of blood cancer in a palliative setting.
Clinician-predicted life expectancy of more than 2 months.
Receiving daily regular strong opioids for cancer pain. Strong opioids are powerful pain-relieving medications.
Receiving a stable scheduled opioid dose for the last 48 hours.
Receiving paracetamol (a common pain reliever) 1 gram three or four times a day for at least five days.
Average pain intensity in the past 24 hours should be between 2 and 7 on a scale from 0 to 10, where 0 means no pain and 10 means the worst pain possible.

Who Cannot Join the Study?

Patients with metastatic cancer disease cannot participate. This means the cancer has spread to other parts of the body.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Sørlandet sykehus Kristiansand	Kristiansand	Norway
Vestre Viken HF	Drammen	Norway
Sykehuset Oestfold HF Kalnes	Graalum	Norway
Helse Forde HF	Foerde	Norway
Sykehuset I Vestfold HF	Tonsberg	Norway
Sndkdtwpn Tppktqst Hb	Skien	Norway
Auhztavx Urdxmzhvtx Hnrevxjb	Lorenskog	Norway
Hctkb Mzanu Oi Rpzpzci He	Aalesund	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	12.08.2021

Trial locations

Investigated drugs:

Paracetamol is a common pain reliever and fever reducer. In this trial, it is being tested to see if stopping its use affects pain control in patients who are also taking strong opioids for cancer-related pain. The study aims to find out if continuing to use paracetamol with opioids provides better pain relief than stopping paracetamol.

Strong Opioids are powerful pain medications used to manage severe pain, often related to cancer. They work by binding to specific receptors in the brain to reduce the perception of pain. In this trial, strong opioids are used in combination with paracetamol to assess their effectiveness in controlling pain when paracetamol is withdrawn.

Investigated diseases:

Metastatic Cancer – Metastatic cancer occurs when cancer cells spread from the primary site to other parts of the body. This process involves cancer cells breaking away from the original tumor, traveling through the bloodstream or lymphatic system, and forming new tumors in other organs or tissues. The progression of metastatic cancer can vary depending on the type of primary cancer and the organs affected. Common sites for metastasis include bones, liver, lungs, and brain. As the disease progresses, it can lead to a range of symptoms depending on the location and size of the metastatic tumors. The spread of cancer cells can disrupt the normal function of affected organs, leading to further complications.

Trial ID:

2024-515012-53-00

Protocol code:

PARASTOP

NCT ID:

NCT05051735

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Paracetamol and Strong Opioids for Pain Relief in Patients with Metastatic Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?