Clinical trial NCT05421416: Loratadine for the Prevention of G-CSF-related Bone Pain
Official title: Loratadine for the Prevention of Bone Pain Caused by Granulocyte Colony Stimulating Factor (G-CSF) During Stem Cell Mobilization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stem Cell Transplant Complications
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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: Inclusion Criteria:

1. A histologically or cytologically documented lymphoma or multiple myeloma
2. Next line of therapy is autologous stem cell transplant
3. Adult ≥ 18 years old.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
5. Life expectancy of at least 12 weeks.
6. 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.
7. Able to adhere to study protocols and visit schedules

Exclusion Criteria:

1. Hypersensitivity or intolerance to antihistamines
2. Use of antihistamines within two days prior to the study period, excepting the use of single dose antihistamines during chemotherapy or blood transfusion protocols.
3. Recent use of G-CSF or pegfilgrastim defined as within 12 weeks of study accrual.
4. New and continued regular use of analgesics within the four days prior to the first dose of G-CSF

Primary outcomes:
measure: Bone Pain Severity (Brief Pain Inventory)
timeFrame: Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12).
measure: Bone Pain Interference (Brief Pain Inventory)
timeFrame: Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12).
measure: Bone pain severity (QLQ-BM22)
timeFrame: QLQ-BM22 will be completed at baseline and at the end of treatment (max day 12).
Secondary outcomes:
measure: Stem cell mobilization efficacy
timeFrame: Single measurement at the end of mobilization protocol (max day 8)
measure: Mean time to stem cell re-engraftment
timeFrame: Single measurement during stem cell re-infusion (max day 8)
measure: Rate of plerixafor use during in each study arm
timeFrame: Single measurement after all patients have completed end of treatment.
measure: Rate of pain control use
timeFrame: Single measurement after all patients complete mobilization (max day 8)
measure: Qualitative breakthrough of pain control use
timeFrame: Qualitative description of analgesic type after all patients complete mobilization (max day 8)
measure: Progression free survival
timeFrame: Patients will be followed for 1 year after completion of the study treatment.
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
References: