Loratadine for the Prevention of G-CSF-related Bone Pain
ConditionStem Cell Transplant Complications
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAHS Cancer Control Alberta
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Loratadine
- Placebo
Treatment groups
78 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov