Loratadine for Stem Cell Transplant Bone Pain

Overseen By Rammy Khadour

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AHS Cancer Control Alberta

Must not be taking: Antihistamines, Analgesics

Disqualifiers: Hypersensitivity to antihistamines, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 days

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether loratadine, an allergy medication, can reduce bone pain associated with G-CSF treatment during stem cell transplants for individuals with lymphoma or multiple myeloma. Participants will receive either loratadine or a placebo (a harmless pill with no active drug) to determine which is more effective for this type of pain. It targets individuals preparing for an autologous stem cell transplant who have lymphoma or multiple myeloma and have not recently used antihistamines or G-CSF. The study aims to make the transplant process less painful and more bearable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop using antihistamines two days before the study starts, except for single doses during chemotherapy or blood transfusions. You also need to stop regular use of pain relievers four days before starting G-CSF.

Is there any evidence suggesting that loratadine is likely to be safe for humans?

Research has shown that loratadine, a common allergy medication, is generally safe. One study found that although loratadine did not significantly reduce severe bone pain, it caused fewer side effects than naproxen, another pain reliever. This suggests loratadine might be a safer choice for some individuals.

In practice, loratadine is sometimes used to alleviate bone pain associated with treatments that boost white blood cell production. This widespread use supports its safety profile. Overall, loratadine appears to have a low risk of serious side effects, making it a potentially safe option for those considering participation in a trial involving this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Loratadine is unique because it's being explored for a new use: alleviating bone pain associated with stem cell transplants. Typically, bone pain from these procedures is managed with standard pain relievers or opioids, which can have significant side effects. Loratadine, commonly known as an allergy medication, offers a potentially safer and more targeted approach by counteracting the effects of G-CSF, a growth factor that can cause bone pain during stem cell mobilization. Researchers are excited about this treatment because it might provide effective pain relief with fewer side effects, making the recovery process easier for patients undergoing stem cell transplants.

What evidence suggests that loratadine might be an effective treatment for bone pain?

This trial will compare Loratadine, a common allergy medicine, with a placebo to assess its effectiveness in reducing bone pain caused by drugs like G-CSF, used in stem cell transplants. Research has shown mixed results regarding Loratadine's effectiveness. For example, one study found that Loratadine did not significantly lessen severe bone pain or improve quality of life in high-risk patients. However, it is sometimes used for this type of bone pain. Although Loratadine's effectiveness in easing pain remains unproven, it is still under active investigation in this trial. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive loratadine or placebo starting 3 hours before the first dose of G-CSF and continue daily for a minimum of 8 days

8-12 days

Daily monitoring (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Loratadine
• Placebo

Trial Overview 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).

How Is the Trial Designed?

Group I: Loratadine Arm Experimental Treatment 1 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 Arm Placebo Group 1 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.

Loratadine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Loratadine for:

• Allergic rhinitis
• Urticaria

Approved in European Union as Loratadine for:

• Allergic rhinitis
• Urticaria

Approved in Canada as Loratadine for:

• Allergic rhinitis
• Urticaria

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

Published Research Related to This Trial

The fixed-dose combination of loratadine and montelukast (L/M) was well tolerated in over 3800 subjects across 19 clinical studies, showing a low incidence of adverse events (AEs) comparable to placebo and individual monotherapies.

The most common adverse event reported was headache (4.5%), but most AEs were mild and short-lived, with no significant changes in laboratory tests or vital signs, indicating that L/M is a safe option for treating allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of fixed-dose loratadine/montelukast in subjects with allergic rhinitis. Prenner, BM., Lu, S., Danzig, MR.[2021]

Severe pain is a common experience for patients undergoing haematopoietic stem cell transplantation (HSCT) at all stages, from stem cell mobilization to long-term recovery.

The primary source of pain during HSCT is damage to mucosal tissues caused by the conditioning regimen, but other pain sources have also been identified, highlighting the need for comprehensive pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain syndromes in the setting of haematopoietic stem cell transplantation for haematological malignancies. Niscola, P., Romani, C., Scaramucci, L., et al.[2011]

In a study involving 107 hay fever patients, loratadine (40 mg once daily) was found to significantly reduce allergy symptoms compared to placebo, outperforming clemastine (1 mg twice daily) in effectiveness.

Loratadine did not cause sedation, while clemastine had a higher sedation rate, making loratadine a safer option for treating hay fever without the drowsiness associated with some antihistamines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of hay fever with loratadine--a new non-sedating antihistamine. Irander, K., Odkvist, LM., Ohlander, B.[2019]

A 6.1-year-old child developed calcineurin-induced pain syndrome (CIPS) after receiving cyclosporine during his second hematopoietic stem cell transplant, with severe leg pain occurring during the drug infusion.

Switching from cyclosporine to tacrolimus and starting amlodipine for hypertension effectively resolved the pain, suggesting that alternative calcineurin inhibitors and calcium-channel blockers may help manage CIPS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyclosporine-induced pain syndrome in a child undergoing hematopoietic stem cell transplant. Lavoratore, SR., Navarro, OM., Grunebaum, E., et al.[2013]

In a 28-day study involving patients with chronic idiopathic urticaria, loratadine (10 mg once daily) was found to be significantly more effective than placebo in reducing symptoms, with 64% of patients reporting marked or complete relief.

Loratadine was well tolerated, showing no sedative or anticholinergic side effects, making it a safer option compared to terfenadine, which had some reported side effects like sedation and dry mouth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effects of loratadine and terfenadine in the treatment of chronic idiopathic urticaria. Belaich, S., Bruttmann, G., DeGreef, H., et al.[2013]

Loratadine is an effective long-acting antihistamine that has been shown to be superior to placebo and as effective as other antihistamines for treating allergic rhinitis and chronic urticaria, based on large clinical studies.

It is well tolerated with fewer sedative effects compared to other antihistamines, making it a suitable first-line treatment option, especially since serious side effects like ventricular arrhythmias have not been reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loratadine. A reappraisal of its pharmacological properties and therapeutic use in allergic disorders. Haria, M., Fitton, A., Peters, DH.[2018]

In a 15-day study involving 30 patients with grass pollen allergies, the combination of 5 mg loratadine and 120 mg pseudoephedrine significantly reduced total allergy symptoms, including nasal stuffiness, sneezing, and eye irritation.

The treatment was well tolerated with no serious side effects reported, and only mild side effects like sedation and dry mouth occurred in 3 to 7 percent of patients, indicating it is both safe and effective for managing seasonal allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the efficiency and safety of the loratadine with pseudoephedrine combination drug in treatment of seasonal allergic rhinitis]. Zawisza, E., Lipiec, A., Rapiejko, P.[2013]

A 42-year-old woman with relapsed Philadelphia-positive acute lymphoblastic leukemia successfully achieved molecular remission after treatment with chemotherapy and imatinib mesylate, followed by a second allogeneic bone marrow transplantation.

She experienced a rare complication known as calcineurin-inhibitor induced pain syndrome (CIPS) after the transplant, which was resolved by stopping the medication and using analgesics, highlighting the need for awareness of this potential side effect in similar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acute lymphoblastic leukemia presenting with calcineurin-inhibitor induced pain syndrome after a second allogeneic bone marrow transplantation]. Takashima, S., Numata, A., Miyamoto, T., et al.[2014]

A 10-year-old boy developed Complex Regional Pain Syndrome (CIPS) after a second allogeneic bone marrow transplant (BMT) for severe aplastic anemia, highlighting a rare complication in pediatric patients post-transplant.

Despite experiencing severe pain and bone marrow edema, the patient's condition improved naturally after 43 days without stopping the tacrolimus treatment, which was within the therapeutic range at the onset of symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcineurin-inhibitor-induced pain syndrome after a second allogeneic bone marrow transplantation for a child with aplastic anemia. Nishikawa, T., Okamoto, Y., Tanabe, T., et al.[2014]

Calcineurin-inhibitor induced pain syndrome (CIPS) is a newly recognized complication in patients receiving immunosuppressive medications, particularly tacrolimus, after transplantation.

This study is significant as it reports the first case of tacrolimus-associated CIPS in pediatric patients, highlighting the need for awareness and management of this pain syndrome in young transplant recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tacrolimus-induced pain syndrome in a pediatric orthotopic liver transplant patient. Malat, GE., Dupuis, RE., Kassman, B., et al.[2019]

Loratadine is a nonsedating antihistamine that effectively relieves symptoms of allergic rhinitis and urticaria, with a quick onset of action within 1 hour and a duration of at least 24 hours, making it suitable for once-daily dosing.

It has a low incidence of sedation and adverse reactions, comparable to placebo, and shows minimal potential for drug interactions, making it a safe option for treating acute allergic reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loratadine: a nonsedating antihistamine with once-daily dosing. Barenholtz, HA., McLeod, DC.[2019]

In an eight-week clinical trial with 25 patients, loratadine significantly improved lung function parameters by up to 21% and reduced apneic events by about 52%, indicating its efficacy as an adjunct treatment for persistent allergic bronchial asthma.

71% of patients reported a good therapeutic response to loratadine, and there was a notable decrease in the use of inhalative sympathomimetics, suggesting that loratadine effectively alleviates asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Allergic bronchial asthma treated with Loratadine]. Kroll, VM., Nothofer, B., Werdermann, K.[2013]

In a study of 139 allergic patients with acute rhinosinusitis, the addition of loratadine to standard treatment (antibiotics and corticosteroids) significantly improved symptoms like sneezing and nasal obstruction compared to placebo.

Patients receiving loratadine showed greater overall improvement as rated by physicians, indicating that loratadine can enhance symptom control in acute sinusitis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunct effect of loratadine in the treatment of acute sinusitis in patients with allergic rhinitis. Braun, JJ., Alabert, JP., Michel, FB., et al.[2019]

Citations

1. oncologynurseadvisor.com oncologynurseadvisor.com/features/bone-pain-due-to-white-blood-cell-growth-factors/

Bone Pain Due to White Blood Cell Growth Factors We sometimes use loratadine (Claritin) to treat bone pain in patients receiving white blood cell growth factors.

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/86/NCT03883386/Prot_SAP_000.pdf

Loratadine for Improvement of Bone Pain in Patients with ... Loratadine for bone pain during chemotherapy​​ This study found no significantly significant difference in bone pain between no prophylaxis, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5266505/

Randomized phase II study of loratadine for the prevention of ... Administration of prophylactic loratadine does not decrease the incidence of severe bone pain or improve quality of life in a high-risk patient population.

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/500115

Loratadine for the Prevention of G-CSF-related Bone Pain The research question for the current study is: Is loratadine more effective than placebo in preventing G-CSF-related bone pain during autologous hematopoetic ...

5. withpower.com withpower.com/trial/early-phase-1-multiple-myeloma-2021-36fd1

Loratadine for Bone Pain in Multiple Myeloma This trial studies if loratadine, an allergy medicine, can reduce bone pain in multiple myeloma patients who are collecting stem cells.

6. ctv.veeva.com ctv.veeva.com/study/loratadine-for-the-prevention-of-g-csf-related-bone-pain

Loratadine for the Prevention of G-CSF-related Bone Pain The research question for the current study is: Is loratadine more effective than placebo in preventing G-CSF-related bone pain during autologous hematopoetic ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-07795

Loratadine for the Reduction of G-CSF Induced Bone Pain ... Loratadine is an antihistamine that may help to reduce or control bone pain during the process of stem cell collection in patients with multiple myeloma.