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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Sao Paulo
Sponsor:
Collaborator:
University of Sao Paulo General Hospital
Information provided by (Responsible Party):
Dov Charles Goldenberg, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01072045
First received: February 18, 2010
Last updated: June 17, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:
  • corticosteroid
  • metilprednisolone

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072045

Contacts
Contact: Dov C Goldenberg, MD +55-11-5539-7741 drdov@terra.com.br
Contact: Lilian M Cristofani, MD +55-11-38973811 drdov@me.com

Locations
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         
Sponsors and Collaborators
University of Sao Paulo
University of Sao Paulo General Hospital
Investigators
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 July 20, 2014