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

Not Applicable

Completed

• Conditions: Cerebral Necrosis
• Interventions: Other: hyperbaric oxygen therapy

• Registration Number: NCT02714465
• Lead Sponsor: Niguarda Hospital

Brief 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)

Detailed 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

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-21
• Primary Completion: 2022-12-01
• Status Verified: 2023-03
• Study Completion: 2023-03-01
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperbaric oxygen therapy	hyperbaric oxygen therapy	All patients underwent radiosurgery with clinical and instrumental signs of cerebral radionecrosis

Primary Outcome Measures

Name	Time	Method
Evaluation of clinical improvement	day 2 through day 25	By neurological evaluation (Ranking Scale)

Secondary Outcome Measures

Name	Time	Method
Evaluation of the reduction of the extent of edema lesion documented by MRI	1-3 months	MRI analysis
Measurement of complications from hyperbaric oxygen therapy and their severity	through study completion, an average of 1 year

Trial Locations

Locations (1)

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milano, Lombardia, Italy