Autonomic Reflexes During Intra-arterial Chemotherapy for Retinoblastoma

Chemotherapy Effect Clinical Trial

Official title:

Cardiorespiratory Autonomic Reflexes During Superselective Ophthalmic Artery Chemotherapy for Retinoblastoma in Children: a Prospective Observational Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451304
• Other study ID #: CAAE 28598120.5.0000.5505
• Status: Recruiting
• Start date: June 15, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: June 2020
• Source: Federal University of São Paulo
• Contact: Mariana F Lima, MD, PhD
• Phone: +551150809236
• Email: marifonteslima[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Prospective observational study in patients undergoing intra-arterial ophthalmic artery chemotherapy for the treatment of retinoblastoma. The main objective of the study is to evaluate the incidence of cardiorespiratory autonomic reflexes in these patients and to investigate the association between autonomic reflexes and perioperative clinical characteristics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• All patients diagnosed with retinoblastoma and submitted to intra-arterial chemotherapy during the study period

• Informed consent form signed and dated by legal guardian and investigator

• Informed assent form signed by the patient if appropriate

Exclusion Criteria:

• Refusal of the patient or guardian to participate in the research project

Related Conditions & MeSH terms

• Chemotherapy Effect
• Retinoblastoma
• Retinoblastoma Bilateral

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory autonomic reflexes incidence	To evaluate the incidence of cardiorespiratory autonomic reflexes during intra-arterial chemotherapy of the ophthalmic artery in a child cancer center.	from the admission of the patient in the operating room until the end of the procedure (intra-arterial chemotherapy)
Secondary	Clinical background and autonomic reflexes occurence	To evaluate the association between perioperative characteristics (both baseline and intraoperative characteristics) and the incidence of cardiorespiratory autonomic reflexes	from the admission of the patient in the operating room until the end of the procedure.