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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2023-03-01

Brief Summary

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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)

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Detailed Description

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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

Conditions

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Cerebral Necrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyperbaric oxygen therapy

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

Group Type EXPERIMENTAL

hyperbaric oxygen therapy

Intervention Type OTHER

hyperbaric oxygen therapy

Interventions

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hyperbaric oxygen therapy

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No