Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)

NCT ID: NCT01074437

Last Updated: 2018-10-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-02-28

Brief Summary

This is a prospective randomized, double-blind study to compare the clinical efficacy of infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy with corticosteroids and placebo. We hypothesize that a two-month treatment period with propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and vascularity when compared to corticosteroids used without propranolol for the same time period.

Detailed Description

Infantile hemangiomas (IH) are the most common head and neck pediatric tumors. Presence of these tumors can lead to complications of vision and airway compromise, bleeding and disfigurement. Medical treatment of these lesions has traditionally been focused on stopping new blood vessel growth with corticosteroids. Recent reports and our own experience have demonstrated that significant reduction in IH size and vascularity can also occur through the use of propranolol. Our initial experience with propranolol has demonstrated significant efficacy with fewer side effects than corticosteroids. Despite this experience, the standard of care for initial IH medical therapy remains corticosteroids.

This Trial is a direct comparison of traditional IH therapy with corticosteroids to newer therapy with propranolol and corticosteroids.

Conditions

Hemangioma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A: Corticosteroid with Placebo

Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.

Group Type: OTHER

Prednisolone (Corticosteroid)

Intervention Type: DRUG

Oral liquid prednisolone. Dose: 1-2mg/kg/day for 7 days, and then dose will be slowly reduced and then stopped after 3 weeks.

Placebo

Intervention Type: DRUG

Liquid placebo will be given during the two month treatment trial.

Group B: Corticosteroid with Propranolol

Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.

Group Type: OTHER

Prednisolone (Corticosteroid)

Intervention Type: DRUG

Oral liquid prednisolone. Dose: 1-2mg/kg/day for 7 days, and then dose will be slowly reduced and then stopped after 3 weeks.

Propranolol

Intervention Type: DRUG

Oral liquid propranolol will be dosed Oral liquid propranolol will be dosed at 2 mg/kg/day.

Interventions

Prednisolone (Corticosteroid)

Oral liquid prednisolone. Dose: 1-2mg/kg/day for 7 days, and then dose will be slowly reduced and then stopped after 3 weeks.

Intervention Type: DRUG

Propranolol

Oral liquid propranolol will be dosed Oral liquid propranolol will be dosed at 2 mg/kg/day.

Intervention Type: DRUG

Placebo

Liquid placebo will be given during the two month treatment trial.

Intervention Type: DRUG

Other Intervention Names

Corticosteroids; Propranolol hydrochloride (USP/EP) Oral Solution; Inactive drug; Inactive substance; Inactive medicine

Eligibility Criteria

Inclusion Criteria

• Age 0 to < 9months
• Patients with clinical, radiographic or histologic diagnosis of infantile hemangioma (IH) requiring medical treatment
• IH patients whose parents desire medical treatment for the IH
• Stable cardiac function

Exclusion Criteria

• IH patients over 9 months of age.
• Hypersensitivity to propranolol
• Untreated heart failure: If the patient has heart failure associated with the hemangioma, propranolol would be initiated after anti-congestive therapy and under observation as an in-patient.
• Atrioventricular (AV) block
• Resting heart < 2 SD of normal*(below)
• Resting blood pressure < 2 SD of normal**(below)
• Wolff-Parkinson-White syndrome (WPW)
• History of unexplained syncope
• Bronchial asthma
• History of impaired renal or liver function
• Diabetes mellitus

• Maximum Eligible Age: 9 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Perkins

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan A Perkins, DO

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

References

Cushing SL, Boucek RJ, Manning SC, Sidbury R, Perkins JA. Initial experience with a multidisciplinary strategy for initiation of propranolol therapy for infantile hemangiomas. Otolaryngol Head Neck Surg. 2011 Jan;144(1):78-84. doi: 10.1177/0194599810390445.

Reference Type: BACKGROUND

PMID: 21493392 (View on PubMed)

Truong MT, Perkins JA, Messner AH, Chang KW. Propranolol for the treatment of airway hemangiomas: a case series and treatment algorithm. Int J Pediatr Otorhinolaryngol. 2010 Sep;74(9):1043-8. doi: 10.1016/j.ijporl.2010.06.001. Epub 2010 Jul 31.

Reference Type: BACKGROUND

PMID: 20674045 (View on PubMed)

Other Identifiers

12901

Identifier Type: -

Identifier Source: org_study_id