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

Sponsor

Niguarda Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02714465

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Cerebral Necrosis	Other: hyperbaric oxygen therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hyperbaric oxygen therapy All patients underwent radiosurgery with clinical and instrumental signs of cerebral radionecrosis	Other: hyperbaric oxygen therapy hyperbaric oxygen therapy

Arm

Intervention/Treatment

Experimental: Hyperbaric oxygen therapy

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

Other: hyperbaric oxygen therapy

hyperbaric oxygen therapy

Outcome Measures

Primary Outcome Measures

Evaluation of clinical improvement [day 2 through day 25]
By neurological evaluation (Ranking Scale)

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ASST Grande Ospedale Metropolitano Niguarda	Milano	Lombardia	Italy	20162

Sponsors and Collaborators

Niguarda Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Niguarda Hospital

ClinicalTrials.gov Identifier:

NCT02714465

Other Study ID Numbers:

644-122015

First Posted:

Mar 21, 2016

Last Update Posted:

Apr 8, 2021

Last Verified:

Apr 1, 2021

Keywords provided by Niguarda Hospital

Hyperbaric Oxygen Therapy; Gamma Knife Radiosurgery

Additional relevant MeSH terms:

Necrosis

Study Results

No Results Posted as of Apr 8, 2021