Actively Recruiting
Loratadine for the Prevention of Bone Pain Caused by Granulocyte Colony Stimulating Factor During Stem Cell Mobilization
Led by AHS Cancer Control Alberta · Updated on 2026-02-05
78
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether loratadine can prevent or lessen bone pain caused by granulocyte colony stimulating factor (G-CSF) during autologous hematopoietic stem cell transplant in patients with lymphoma or multiple myeloma. The trial is a phase 2 study evaluating if loratadine is more effective than a placebo in this setting. The goal is to see if loratadine can reduce the severity of G-CSF-related bone pain in these patients. Participants will be randomly assigned to receive either loratadine 10 mg or a placebo capsule. The medication is started 3 hours before the first dose of G-CSF during the stem cell mobilization process and continued daily for at least 8 days. The study uses a triple-blind design to compare the effects of loratadine versus placebo. During the study, participants will complete pain assessments using the Brief Pain Inventory daily and the QLQ-BM22 questionnaire at the start and end of treatment (up to 12 days). Researchers will also monitor stem cell mobilization effectiveness, time to stem cell re-engraftment, use of additional medications for pain and mobilization, and progression-free survival for one year after treatment. Participants' adherence to the protocol and safety will be closely monitored throughout the study period.
CONDITIONS
Brief Title
Loratadine for the Prevention of G-CSF-related Bone Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A histologically or cytologically documented lymphoma or multiple myeloma
- Scheduled for autologous stem cell transplant as next line of therapy
- Adult aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Life expectancy of at least 12 weeks
- No poorly controlled systemic diseases that pose significant risk, including congestive heart failure, diabetes, cirrhosis or liver failure, and renal failure
- Able to follow study protocols and visit schedules
You will not qualify if you...
- Allergy or intolerance to antihistamines
- Use of antihistamines within two days prior to the study, except single doses during chemotherapy or blood transfusion
- Use of G-CSF or pegfilgrastim within 12 weeks before study start
- New and regular use of pain medications within four days before the first G-CSF dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 days
Participants receive loratadine or placebo starting 3 hours before the first dose of G-CSF and continue daily for at least 8 days during stem cell mobilization.
Daily visits or assessments during treatment (up to 12 days)
Duration - 1 year
Participants are followed for 1 year after completing treatment to monitor progression-free survival and other long-term outcomes.
Periodic visits during follow-up
Trial Site Locations
Total: 1 location
1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
Research Team
M
Michael Chu, MD
R
Rammy Khadour
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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