Loratadine for the Prevention of Bone Pain Caused by Granulocyte Colony Stimulating Factor (G-CSF) During Stem Cell Mobilization
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Bone Pain Interference (Brief Pain Inventory)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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
排除标准
- •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
研究组 & 干预措施
Loratadine Arm
Loratadine 10mg, administered initially 3 hours before the first dose of G-CSF in the autologous stem cell mobilization protocol, and then daily for a minimum of 8 days.
干预措施: Loratadine (Drug)
Placebo Arm
Placebo capsule, administered initially 3 hours before the first dose of G-CSF in the autologous stem cell mobilization protocol, and then daily for a minimum of 8 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Bone Pain Interference (Brief Pain Inventory)
时间窗: Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12).
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).
Bone pain severity (QLQ-BM22)
时间窗: QLQ-BM22 will be completed at baseline and at the end of treatment (max day 12).
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).
Bone Pain Severity (Brief Pain Inventory)
时间窗: Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12).
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).
次要结局
- Rate of pain control use(Single measurement after all patients complete mobilization (max day 8))
- Qualitative breakthrough of pain control use(Qualitative description of analgesic type after all patients complete mobilization (max day 8))
- Mean time to stem cell re-engraftment(Single measurement during stem cell re-infusion (max day 8))
- Rate of plerixafor use during in each study arm(Single measurement after all patients have completed end of treatment.)
- Progression free survival(Patients will be followed for 1 year after completion of the study treatment.)
- Stem cell mobilization efficacy(Single measurement at the end of mobilization protocol (max day 8))