Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Infantile Hemangioma

NCT01072045 | Completed Phase 2

• 1 other identifier: CAPPesq0931/09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Infantile Hemangioma (IH) is infancy's most common vascular tumor of infancy and most frequent benign neoplasm. Treatment of IHs is indicated for approximately 10 to 20% of the cases. Two groups can be defined amongst indications for treatment: patients with absolute indication for treatment and patients with relative indication for treatment. Absolute or emergency indications comprise function or life threatening situations such as obstruction of airways, obstruction of vision, congestive heart failure, hepatic and coagulation problems. The following are considered relative indications: cases of large and disfiguring facial hemangiomas; locations that can result in a deformity and/ or permanent scar (nose, ear, lip, glabellar area); extensive face hemangiomas, mainly when there is dermal damage (more probable to scar); local complications such as ulceration, infection and bleeding as well as small hemangiomas in exposed areas (hands and face), mainly if pedunculated due to its ease of excision2,7. Treatment modalities vary according to the extension, location, presence of complications and the evolutional phase. A combination of various treatments is possible. Beta blockers are being used in children for approximately 40 years, with proven clinical safety and no cases of death or cardiovascular disease resulting from its direct use. Recently it was reported the use of beta blockers (propanolol) for IH treatment, with significant reduction of tumor volume after introduction of the beta blocker, in a short period of time, with stable results after the end of treatment, which suggested evidences of the benefits of this drug in the tumor treatment The proposal of this study is to assess the use of propanolol in IH treatment, quantifying its effectiveness and safety under continuous monitoring and comparing it to the use of oral corticosteroid. The investigators propose the assessment of the betablockers' use in comparison to the use of corticosteroids in infants with IH in the proliferative or involuting phases, with indication for clinical treatment, and that are not alarming nor urgent; in other words, the current relative indications for treatment.

Conditions

Hemangioma

Keywords

Hemangioma; Proliferative hemangioma; Treatment; Propranolol; Corticosteroid

Outcome Measures

Primary Outcomes (1)

• Reduction on tumor volume, based on direct measurement (in centimeters, 2 axis) and photographic analysis (same photo camera, obtained by the same technician)

  weekly in the first two months and twice a week in the following months

Secondary Outcomes (1)

• evidence of collateral effects

  weekly on the first 2 weeks and twice a week on the following months

Study Arms (2)

Propranolol

ACTIVE COMPARATOR

Oral propranolol, at a dose of 2mg/kg/day, divided in 2 doses.

Drug: Propranolol

Prednisone

ACTIVE COMPARATOR

Oral prednisone , at a dose of 2mg/kg/day, divided in 2 doses.

Drug: Prednisone

Interventions

Propranolol DRUG

Oral propranolol, at a dose of 2mg/kg/day, divided in 2 doses, for initial 60 days

Also known as: beta-blockers

Propranolol

Prednisone DRUG

Oral prednisone, at a dose of 2mg/kg/day, divided in 2 doses, for initial 60 days

Also known as: corticosteroid, metilprednisolone

Prednisone

Eligibility Criteria

• Age: 10 Days - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with ages up to 2 years;
• Clinically diagnosed hemangioma, in proliferative or involutive phase, with relative indication for clinical treatment, as itemized:
• lesion causing alteration of regional anatomy with no systemic or functional damage and with a diameter greater than 1 centimeter, or
• lesion causing aesthetic deformity, or
• lesion causing local repetitive complications such as ulceration, bleeding or local infection, or
• lesion causing partial damage of orifices, or
• lesion causing psychological compromise.
• Absence of cardiopathy (normal physical examination, anamnesis, echocardiography, electrocardiography and thoracic radiography);
• Informed consent signed by responsible parties

You may not qualify if:

• Hemangioma with absolute indication for treatment, presenting a risk to function or life;
• Patients with previous treatment for infantile hemangiomas;
• Cardiac disease;
• Pulmonary disease (asthma, bronchiolitis,bronchopulmonary dysplasias)
• Raynaud syndrome;
• Pheochromocytoma;
• Altered echocardiography, even if asymptomatic

Sponsors & Collaborators

• University of Sao Paulo: lead
• University of Sao Paulo General Hospital: collaborator

Study Sites (1)

Instituto de Tratamento do Câncer Infantil (Pediatric Cancer Treatment Institute) - ITACI - ICr-HCFMUSP (Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo)

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (11)

• Lawley LP, Siegfried E, Todd JL. Propranolol treatment for hemangioma of infancy: risks and recommendations. Pediatr Dermatol. 2009 Sep-Oct;26(5):610-4. doi: 10.1111/j.1525-1470.2009.00975.x.

  PMID: 19840322 BACKGROUND

• Frieden IJ, Drolet BA. Propranolol for infantile hemangiomas: promise, peril, pathogenesis. Pediatr Dermatol. 2009 Sep-Oct;26(5):642-4. doi: 10.1111/j.1525-1470.2009.00977.x. No abstract available.

  PMID: 19840341 BACKGROUND

• Maturo S, Hartnick C. Initial experience using propranolol as the sole treatment for infantile airway hemangiomas. Int J Pediatr Otorhinolaryngol. 2010 Mar;74(3):323-5. doi: 10.1016/j.ijporl.2009.12.008. Epub 2010 Jan 13.

  PMID: 20071038 BACKGROUND

• Buckmiller LM. Propranolol treatment for infantile hemangiomas. Curr Opin Otolaryngol Head Neck Surg. 2009 Dec;17(6):458-9. doi: 10.1097/MOO.0b013e328332a4eb.

  PMID: 19858718 BACKGROUND

• Mousa W, Kues K, Haas E, Lauerer P, Pavlakovic H, Schon MP, Zutt M. Successful treatment of a large hemangioma with propranolol. J Dtsch Dermatol Ges. 2010 Mar;8(3):184-6. doi: 10.1111/j.1610-0387.2009.07266.x. Epub 2009 Sep 25. English, German.

  PMID: 19788583 BACKGROUND

• Perez RS, Mora PC, Rodriguez JD, Sanchez FR, de Torres Jde L. [Treatment of infantile hemangioma with propranolol]. An Pediatr (Barc). 2010 Feb;72(2):152-4. doi: 10.1016/j.anpedi.2009.05.019. Epub 2009 Jul 23. No abstract available. Spanish.

  PMID: 19631595 BACKGROUND

• Denoyelle F, Leboulanger N, Enjolras O, Harris R, Roger G, Garabedian EN. Role of Propranolol in the therapeutic strategy of infantile laryngotracheal hemangioma. Int J Pediatr Otorhinolaryngol. 2009 Aug;73(8):1168-72. doi: 10.1016/j.ijporl.2009.04.025. Epub 2009 May 29.

  PMID: 19481268 BACKGROUND

• Michel JL, Patural H. [Response to oral propranolol therapy for ulcerated hemangiomas in infancy]. Arch Pediatr. 2009 Dec;16(12):1565-8. doi: 10.1016/j.arcped.2009.09.008. Epub 2009 Nov 4. French.

  PMID: 19892536 BACKGROUND

• Siegfried EC, Keenan WJ, Al-Jureidini S. More on propranolol for hemangiomas of infancy. N Engl J Med. 2008 Dec 25;359(26):2846; author reply 2846-7. doi: 10.1056/NEJMc086443. No abstract available.

  PMID: 19109584 BACKGROUND

• Leaute-Labreze C, Taieb A. [Efficacy of beta-blockers in infantile capillary haemangiomas: the physiopathological significance and therapeutic consequences]. Ann Dermatol Venereol. 2008 Dec;135(12):860-2. doi: 10.1016/j.annder.2008.10.006. Epub 2008 Nov 20. No abstract available. French.

  PMID: 19084699 BACKGROUND

• Leaute-Labreze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taieb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819. No abstract available.

  PMID: 18550886 BACKGROUND

Related Links

• website of the International Society for the Study of Vascular Anomalies

MeSH Terms

Conditions

Hemangioma

Interventions

Propranolol; Adrenergic beta-Antagonists; Prednisone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Dov C Goldenberg, MD

  Division of Plastic Surgery - Hospital das Clinicas - University of Sao Paulo School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Division of Plastic Surgery, Haspital dasd Clinicas, University of Sao Paulo

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

BR (1)