Status:
RECRUITING
Loratadine for the Prevention of G-CSF-related Bone Pain
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
Stem Cell Transplant Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 lym...
Eligibility Criteria
Inclusion
- A histologically or cytologically documented lymphoma or multiple myeloma
- Next line of therapy is autologous stem cell transplant
- Adult ≥ 18 years old.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Life expectancy of at least 12 weeks.
- The absence of any additional poorly controlled systemic disease that is directly contraindicated or places subject at significant risk, including but not limited to: congestive heart failure, diabetes mellitus, cirrhosis or liver failure, renal failure.
- Able to adhere to study protocols and visit schedules
Exclusion
- Hypersensitivity or intolerance to antihistamines
- Use of antihistamines within two days prior to the study period, excepting the use of single dose antihistamines during chemotherapy or blood transfusion protocols.
- Recent use of G-CSF or pegfilgrastim defined as within 12 weeks of study accrual.
- New and continued regular use of analgesics within the four days prior to the first dose of G-CSF
Key Trial Info
Start Date :
November 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05421416
Start Date
November 28 2024
End Date
December 1 2026
Last Update
January 29 2025
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2