Recruiting
Phase 2

Loratadine

Sponsor:

AHS Cancer Control Alberta

Code:

NCT05421416

Conditions

Stem Cell Transplant Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Loratadine

Placebo

Study Details

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.

Conditions

Stem Cell Transplant Complications

Study ID

NCT05421416

Start date

Nov 28, 2024

Status verified date

Feb, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

Interventions

Loratadine

Loratadine is 2nd generation inverse agonist that exerts its effect by targeting H1 histamine receptors.

Placebo

Placebo sugar pill

Primary outcome measure

  • Bone Pain Severity (Brief Pain Inventory) [ Time Frame: Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12). ]
  • Bone Pain Interference (Brief Pain Inventory) [ Time Frame: Brief Pain Inventory will be completed at baseline, daily during treatment (up to 12 days) and at the end of treatment (max day 12). ]
  • Bone pain severity (QLQ-BM22) [ Time Frame: QLQ-BM22 will be completed at baseline and at the end of treatment (max day 12). ]

Central Contacts and Locations

Central contacts

Michael Chu, MD

780-432-8757Michael.Chu@ahs.ca

Rammy Khadour

780-432-8795Rammy.Khadour@ahs.ca

Locations

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2026-02-05.