Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use

Study Overview
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Brief Summary
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G-CSF causes a release of histamine that may be a cause of chronic bone pain. Loratadine targets histamine, and so may be effective in reducing bone pain.The researchers plan to prospectively assess the effectiveness of loratadine for chronic bone pain in patients with chronic G-CSF use.

Official Title
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Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use

Conditions
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Bone Pain

Intervention / Treatment
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* Drug: Loratadine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of neutropenia Granulocyte-colony stimulating factor (G-CSF) use for at least 3 months at least 4 times per month Mean bone pain of at least a 2/10 as assessed by questions 3-6 of the Brief Pain Inventory (BPI) Exclusion Criteria: Other sources of chronic pain Previously tried loratadine for 7 consecutive days or more for bone pain Allergy to loratadine Chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loratadine first<br>Take treatment daily for 7 days. | Drug: Loratadine<br>* 10 mg in a capsule<br>* Other names: Claritin;Drug: Placebo<br>* Administered via capsule<br>|
| Placebo Comparator: Placebo first<br>Take placebo daily for 7 days. | Drug: Loratadine<br>* 10 mg in a capsule<br>* Other names: Claritin;Drug: Placebo<br>* Administered via capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Severity Scores as Measured by the Brief Pain Inventory (BPI) | The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The questions ask participants to rate their pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where 0 indicates No pain and 10 indicates Pain as bad as you can imagine. Modified BPI: Included the pain intensity subscale, it is a Numerical Rating Scale with 4 questions (3-6): each item is ranked where 0 is no pain - 10 the worst pain. The Modified BPI will be measured on Days 2, 4, and 6. The full BPI will be measured on Day 7. On day 7 only responses from questions 3-6 will be analyzed for this outcome and a mean composite score for Days 2, 4, 6, and 7 will be calculated. | Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Interference in Patients as Measured by the Brief Pain Inventory (BPI) | Brief Pain Inventory (BPI) asks the participant to rate how their pain interferes with daily activities where 0 indicates does not interfere and 10 indicates completely interferes. The Pain Intensity Scale scores (Numerical Rating Scale (NRS)) for 7 questions: general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life from (BPI question 9A-G); 0 no life interference - 10 complete interference. Pain interference will be assessed on day 7 of each week. | Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Granulocyte-colony stimulating factor