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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Loratadine
DrugLoratadine is 2nd generation inverse agonist that exerts its effect by targeting H1 histamine receptors.
Placebo
DrugPlacebo sugar pill
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Loratadine ArmExperimental treatment 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bone Pain Severity (Brief Pain Inventory)
Reduction in bone pain will be measured as a change from pre-G-CSF baseline in the Brief Pain Inventory (BPI), with median values compared for each trial arm. BPI pain severity will be compared as a composite score (sum of individual pain values divided by 4).
Time frame
Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12).2
Bone Pain Interference (Brief Pain Inventory)
Reduction on impact on daily life as a composite score out of 10 as measured on the Brief Pain Inventory (BPI). BPI pain interference will be compared as a composite score (sum of individual pain interference values divided by 7).
Time frame
Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12).3
Bone pain severity (QLQ-BM22)
Change in bone pain measured pre and post G-CSF in EORTC QLQ-BM22. QLQ-BM22 questionnaires will be compared to the post vs pre-treatment values and calculated as a composite sum (i.e. pre-treatment total score subtracted from post-treatment total score).
Time frame
QLQ-BM22 will be completed at baseline and at the end of treatment (max day 12).Secondary outcomes
1
Stem cell mobilization efficacy
Normalized mean and absolute number number of stem cells collected at the end of the mobilization protocol
Time frame
Single measurement at the end of mobilization protocol (max day 8)2
Mean time to stem cell re-engraftment
Time in days between stem cell re-infusion and the measurement on complete blood count (CBC) of an absolute neutrophil count of greater than 500/mm3 for 3 consecutive days.
Time frame
Single measurement during stem cell re-infusion (max day 8)3
Rate of plerixafor use during in each study arm
Proportion of patients in each study arm that require use of plerixafor during stem cell mobilization
Time frame
Single measurement after all patients have completed end of treatment.4
Rate of pain control use
Proportion of patients in each study arm that require use of additional pain control methods while receiving G-CSF.
Time frame
Single measurement after all patients complete mobilization (max day 8)Sponsors and contacts
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Source ClinicalTrials.gov