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

Niguarda Hospital

Status: Completed

Conditions: Cerebral Necrosis

Treatments: Other: hyperbaric oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02714465

644-122015

Details and patient eligibility

About

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)

Full 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

Enrollment: 65 patients

Sex: All

Ages: 10 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Hyperbaric oxygen therapy

Experimental group

Description:

All patients underwent radiosurgery with clinical and instrumental signs of cerebral radionecrosis

Treatment:

Other: hyperbaric oxygen therapy