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Antihistamine
Loratadine for Stem Cell Transplant Bone Pain
Phase 2
Waitlist Available
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A histologically or cytologically documented lymphoma or multiple myeloma
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be followed for 1 year after completion of the study treatment.
Awards & highlights
Study Summary
This trial is testing whether the drug loratadine is better than a placebo at preventing bone pain in cancer patients undergoing stem cell transplants.
Who is the study for?
This trial is for adults over 18 with lymphoma or multiple myeloma who are about to have a stem cell transplant. They should be relatively healthy, able to follow the study plan, and not have used antihistamines or painkillers recently. People with severe diseases like heart failure or diabetes that aren't well-managed can't join.Check my eligibility
What is being tested?
The trial is testing if Loratadine, an antihistamine, can prevent or lessen bone pain caused by G-CSF injections in patients undergoing stem cell transplants compared to a placebo (a substance with no active drug).See study design
What are the potential side effects?
Loratadine may cause drowsiness, headache, increased appetite, difficulty sleeping, dry mouth and fatigue. However, it's generally considered safe with minimal side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is either lymphoma or multiple myeloma, confirmed by lab tests.
Select...
I am able to care for myself and perform daily activities.
Select...
I do not have any severe illnesses like heart failure, uncontrolled diabetes, liver or kidney failure.
Select...
My next treatment is a stem cell transplant using my own cells.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients will be followed for 1 year after completion of the study treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be followed for 1 year after completion of the study treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bone Pain Interference (Brief Pain Inventory)
Bone Pain Severity (Brief Pain Inventory)
Bone pain severity (QLQ-BM22)
Secondary outcome measures
Mean time to stem cell re-engraftment
Progression free survival
Qualitative breakthrough of pain control use
+3 moreSide effects data
From 2014 Phase 3 trial • 84 Patients • NCT02007434100%
Injection site haemorrhage
100%
Injection site induration
100%
Injection site oedema
100%
Injection site pain
76%
Injection site discomfort
18%
Injection site pruritus
18%
Headache
12%
Injection site erythema
12%
Oropharyngeal pain
6%
Injection site anaesthesia
6%
Injection site nodule
6%
Viral infection
6%
Skin tightness
6%
Injection site rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paradigm 1 / Deoxycholic Acid Injection
Paradigm 1 / Placebo
Paradigm 3 / Deoxycholic Acid Injection
Paradigm 2 / Deoxycholic Acid Injection
Paradigm 2 / Placebo
Paradigm 3 / Placebo
Paradigm 4 / Deoxycholic Acid Injection
Paradigm 4 / Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Loratadine ArmExperimental Treatment1 Intervention
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.
Group II: Placebo ArmPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Loratadine
FDA approved
Find a Location
Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,134 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is either lymphoma or multiple myeloma, confirmed by lab tests.I am able to care for myself and perform daily activities.I do not have any severe illnesses like heart failure, uncontrolled diabetes, liver or kidney failure.I haven't taken antihistamines in the last two days, except a single dose during chemotherapy or a blood transfusion.I have started or continued taking pain medication regularly in the last four days.I have not used G-CSF or pegfilgrastim in the last 12 weeks.My next treatment is a stem cell transplant using my own cells.You are allergic or have a bad reaction to antihistamines.I am 18 years old or older.You are expected to live for at least 12 more weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Loratadine Arm
- Group 2: Placebo Arm
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment presently recruiting?
"As stated on clinicaltrials.gov, this study is not presently signing up participants. Initially posted on November 1st 2022, the trial has since been updated most recently on June 13th 2022. Although no longer recruiting patients for this specific medical experiment, 30 other trials are currently looking to enrol individuals in their studies."
Answered by AI
Is Loratadine a viable option for mitigating patient risk?
"Loratadine's relative safety was determined to be a 2 by our Power team, as the drug is currently in Phase 2 trials and thus has limited data backing its efficacy."
Answered by AI
What is the ultimate goal of this research endeavor?
"This clinical trial is primarily focused on assessing the efficacy of G-CSF in relieving bone pain, as measured by a Bone Pain Interference score from a Brief Pain Inventory. Secondary objectives include measuring Mean Time to Stem Cell Re-engraftment, Progression Free Survival and Qualitative Breakthrough of Pain Control Use."
Answered by AI
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