RecruitingPHASE2INTERVENTIONAL

Loratadine for the Prevention of G-CSF-related Bone Pain

This research is investigating if a common allergy medication, loratadine, can reduce or prevent bone pain that sometimes occurs during a specific type of stem cell transplant. This transplant is used to treat conditions like lymphoma or multiple myeloma. Many patients receive a medicine called G-CSF to help their body produce new blood cells after the transplant, but this can sometimes cause bone pain. We want to find out if taking loratadine could help with this side effect. Participants will be given either loratadine or a placebo (a pill with no active medicine) to see which is more effective. The aim is to make the transplant process more comfortable for patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

AHS Cancer Control Alberta

Enrolment target

Start

28 Nov 2024

Estimated completion

01 Dec 2026

Stem Cell Transplant Complications

What is this study about?

When people with certain blood cancers, like lymphoma or multiple myeloma, have a stem cell transplant, they often receive a treatment called G-CSF. This medicine helps their body make new, healthy blood cells. While G-CSF is very helpful, it can sometimes cause a side effect known as bone pain, which can be uncomfortable for patients.

This study is trying to find a way to prevent or reduce this bone pain. We're testing a medicine called loratadine, which you might know as an antihistamine, often used for allergies like hay fever. We want to see if taking loratadine before and during G-CSF treatment can make a difference in how much bone pain people experience, or if it can stop the pain from happening in the first place.

To do this, we will compare loratadine to a 'placebo', which is a pill that looks exactly like the study medicine but doesn't contain any active drug. This helps us understand if any improvements are truly due to loratadine or to other factors. If loratadine proves effective, it could offer a simple way to make the stem cell transplant process more comfortable for many patients in the future.

Key takeaways

This study is testing if an allergy medicine (loratadine) can prevent bone pain.
Bone pain can be a side effect of G-CSF treatment after a stem cell transplant.
Participants will receive either loratadine or a dummy pill (placebo).
The study is for adults with lymphoma or multiple myeloma having a transplant.
Your comfort and safety are a top priority throughout the study.
This research aims to improve future patient care after stem cell transplants.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with lymphoma or multiple myeloma. You need to be planning to have a 'stem cell transplant' as your next treatment step. To ensure you're well enough for the study, doctors will check your general health, including your heart, kidneys, and liver, to make sure there are no other serious health problems.

There are also some reasons why you might not be able to join. For example, if you're allergic to antihistamine medicines like loratadine, or if you've recently taken certain G-CSF medicines within the last 12 weeks. Also, if you regularly take strong pain medications, this might affect whether you can take part.

Most importantly, you need to be able to follow the study instructions and attend all your appointments, as this helps us collect accurate information. The study team will discuss all these points with you to see if it's a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have lymphoma or multiple myeloma?
Are you planning to have a stem cell transplant soon?
Are you able to attend all clinic appointments and follow instructions?
Are you NOT allergic to usual allergy medicines?
Have you NOT taken G-CSF (bone-marrow stimulant) in the last 12 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either loratadine or a placebo pill to take regularly during your stem cell transplant. You won't know which one you're receiving, and neither will your doctors. You'll need to keep track of any bone pain you experience, likely by filling in some simple forms or questionnaires. The team will regularly check in with you to see how you're feeling and monitor your health through standard blood tests and check-ups.

The study will involve several visits to the clinic, which will be scheduled around your transplant treatment. You'll be asked to take the study medicine for a specific period, usually coinciding with when you receive G-CSF. The medical team will explain the exact schedule for taking the medication, attending appointments, and completing assessments, so you know exactly what to expect from beginning to end.

Potential risks and benefits

Taking part in this study may or may not directly benefit you, as we are still learning if loratadine helps with bone pain in this setting. However, your participation could help other patients in the future by providing valuable information. Loratadine is generally well-tolerated, and side effects are usually mild, such as drowsiness or dry mouth, which are similar to those you might experience with over-the-counter allergy medicines. There are no additional risks beyond those usually associated with your stem cell transplant. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Cross Cancer Institute
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is bone pain related to G-CSF?

G-CSF is a medicine given after a stem cell transplant to help your body make new blood cells. Sometimes, this can cause an aching pain in your bones, especially in your legs, arms, and back.

What is loratadine?

Loratadine is a common medicine used to treat allergies like hay fever. It's often available without a prescription and helps to reduce symptoms like sneezing and itchy eyes.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study drug but doesn't contain any active medicine. It helps us compare and see if the real drug is truly making a difference.

Will I know if I'm getting loratadine or the placebo?

No, neither you nor your doctors will know whether you are receiving loratadine or the placebo. This is to ensure the results are as unbiased and accurate as possible.

Can I stop taking part in the study if I change my mind?

Yes, absolutely. You are free to withdraw from the study at any time, for any reason, and it will not affect your usual medical care.

How to find out more

Michael Chu, MD

michael.chu@ahs.ca 780-432-8757 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.