Adverse Radiation Effects After Gamma Knife Radio Surgery and Hyperbaric Oxygen Therapy

Cerebral Necrosis Clinical Trial

— GKSHBO  

Official title:

Treatment of Adverse Radiation Effects After Gamma Knife Radiosurgery (GKS) by Hyperbaric Oxygen Therapy (HBO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714465
• Other study ID #: 644-122015
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of clinical improvement and the reduction of edema lesion documented by magnetic resonance imaging (MRI) in patients with cerebral radiation necrosis post gamma knife surgery (GKS) by treatment with hyperbaric oxygen therapy (HBO)

Description:

Patients will be recruited on the basis of the presence of cerebral radionecrosis post gamma knife surgery, documented by both clinical examination (Rankin Scale) and instrumental imaging (MRI). They will be subjected to hyperbaric oxygen therapy HBO, and during treatment the patient performs clinical examination (Rankin Scale) for 24 sessions of HBO. Then they will have a break of 10-15 days during which also performs the instrumental survey (Magnetic Resonance Imaging). If the radionecrosis has regressed they will suspend the treatment otherwise continue up to a maximum of 40 treatment sessions of HBO

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 75 Years

Eligibility

Inclusion Criteria:

• between 10 and 75 years

• understanding of the Italian language

• ability to understand the procedures and carrying out of the study

• signing informed consent for adults and minors in use

• underwent radiosurgery with clinical and instrumental signs of radiation necrosis

Exclusion Criteria:

• younger than 10yrs old and older than 75yrs old

• not capable to understand Italian language or to understand the protocol procedures and visits' scheme

• informed consent not given

• enrolled in another clinical trial

• concomitant pathologies contraindicate HBO as: emphysema, asthma, epilepsy, claustrophobia; Paul Bert Syndrome, Lorrain Smith Syndrome

• under disulfiram, doxorubicine, cisplatinum, mafenide acetate, bleomycins treatment

• life expectancy less than 6 months

• Rankin Scale >5

Related Conditions & MeSH terms

• Cerebral Necrosis
• Necrosis

Intervention

Other:
• hyperbaric oxygen therapy
hyperbaric oxygen therapy

Locations

Country	Name	City	State
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of clinical improvement	By neurological evaluation (Ranking Scale)	day 2 through day 25
Secondary	Evaluation of the reduction of the extent of edema lesion documented by MRI	MRI analysis	1-3 months
Secondary	Measurement of complications from hyperbaric oxygen therapy and their severity		through study completion, an average of 1 year