RecruitingPhase 2NCT05421416

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

Loratadine for the Prevention of Bone Pain Caused by Granulocyte Colony Stimulating Factor (G-CSF) During Stem Cell Mobilization


Sponsor

AHS Cancer Control Alberta

Enrollment

78 participants

Start Date

Nov 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The research question for the current study is: Is loratadine more effective than placebo in preventing G-CSF-related bone pain during autologous hematopoetic stem cell transplant in patients with lymphoma or multiple myeloma? The hypothesis is that prophylaxis with loratadine will help prevent or reduce the severity of bone pain in this setting.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether the common antihistamine loratadine (Claritin) can prevent the bone pain that many cancer patients experience when given G-CSF injections (a medication that stimulates white blood cell production after chemotherapy or stem cell transplant). Bone pain from G-CSF can be quite severe, and loratadine is already known to help — this trial aims to confirm its effectiveness. You may be eligible if... - You have been diagnosed with lymphoma or multiple myeloma (confirmed by lab testing) - Your next planned treatment is an autologous stem cell transplant - You are 18 years of age or older - Your performance status is ECOG 0–2 (able to carry out daily activities with mild limitations) - You have a life expectancy of at least 12 weeks - You are able to follow the study schedule and visits You may NOT be eligible if... - You have a known allergy or intolerance to antihistamines - You used antihistamines within two days before the study - You used G-CSF or pegfilgrastim within the past 12 weeks - You have been regularly taking pain relievers within four days before your first G-CSF dose Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLoratadine

Loratadine is 2nd generation inverse agonist that exerts its effect by targeting H1 histamine receptors.

DRUGPlacebo

Placebo sugar pill


Locations(1)

Cross Cancer Institute

Edmonton, Alberta, Canada

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NCT05421416


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