Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Infantile Hemangioma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemangioma |
Drug: Propranolol Drug: Prednisone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Proliferative and Involuting Cutaneous Infantile Hemangioma |
- Reduction on tumor volume, based on direct measurement (in centimeters, 2 axis) and photographic analysis (same photo camera, obtained by the same technician) [ Time Frame: weekly in the first two months and twice a week in the following months ] [ Designated as safety issue: No ]
- evidence of collateral effects [ Time Frame: weekly on the first 2 weeks and twice a week on the following months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Propranolol
Oral propranolol, at a dose of 2mg/kg/day, divided in 2 doses.
|
Drug: Propranolol
Oral propranolol, at a dose of 2mg/kg/day, divided in 2 doses, for initial 60 days
Other Name: beta-blockers
|
|
Active Comparator: Prednisone
Oral prednisone , at a dose of 2mg/kg/day, divided in 2 doses.
|
Drug: Prednisone
Oral prednisone, at a dose of 2mg/kg/day, divided in 2 doses, for initial 60 days
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 2 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Dov C Goldenberg, MD | +55-11-5539-7741 | drdov@terra.com.br |
| Contact: Lilian M Cristofani, MD | +55-11-38973811 | drdov@me.com |
| Brazil | |
| 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) | Recruiting |
| Sao Paulo, Brazil, 05403-900 | |
| Contact: Dov C Goldenberg, MD +55-11- 5539-7741 drdov@me.com | |
| Contact: Lilian M Cristofani, MD +55-11-38973811 drdov@me.com | |
| Principal Investigator: Dov C Goldenberg, MD | |
| Study Director: | Dov C Goldenberg, MD | Division of Plastic Surgery - Hospital das Clinicas - University of Sao Paulo School of Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | Dov Charles Goldenberg, Professor of Surgery, Division of Plastic Surgery, Haspital dasd Clinicas, University of Sao Paulo, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01072045 History of Changes |
| Other Study ID Numbers: | CAPPesq0931/09 |
| Study First Received: | February 18, 2010 |
| Last Updated: | June 17, 2013 |
| Health Authority: | Brazil: Ethics Committee Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo:
|
Hemangioma Proliferative hemangioma Treatment Propranolol Corticosteroid |
Additional relevant MeSH terms:
|
Hemangioma Hemangioma, Capillary Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Adrenergic beta-Antagonists Propranolol Prednisone Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Vasodilator Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013