Back to resultsAdverse Radiation Effects After Gamma Knife Radio Surgery and Hyperbaric Oxygen Therapy (GKSHBO)
Primary Purpose
Cerebral Necrosis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
hyperbaric oxygen therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Necrosis focused on measuring Hyperbaric Oxygen Therapy; Gamma Knife Radiosurgery
Eligibility Criteria
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
Sites / Locations
- ASST Grande Ospedale Metropolitano Niguarda
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyperbaric oxygen therapy
Arm Description
All patients underwent radiosurgery with clinical and instrumental signs of cerebral radionecrosis
Outcomes
Primary Outcome Measures
Evaluation of clinical improvement
By neurological evaluation (Ranking Scale)
Secondary Outcome Measures
Evaluation of the reduction of the extent of edema lesion documented by MRI
MRI analysis
Measurement of complications from hyperbaric oxygen therapy and their severity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02714465
Brief Title
Adverse Radiation Effects After Gamma Knife Radio Surgery and Hyperbaric Oxygen Therapy
Acronym
GKSHBO
Official Title
Treatment of Adverse Radiation Effects After Gamma Knife Radiosurgery (GKS) by Hyperbaric Oxygen Therapy (HBO)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
March 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Niguarda Hospital
4. Oversight
Data Monitoring Committee
No
5. 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)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Necrosis
Keywords
Hyperbaric Oxygen Therapy; Gamma Knife Radiosurgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyperbaric oxygen therapy
Arm Type
Experimental
Arm Description
All patients underwent radiosurgery with clinical and instrumental signs of cerebral radionecrosis
Intervention Type
Other
Intervention Name(s)
hyperbaric oxygen therapy
Intervention Description
hyperbaric oxygen therapy
Primary Outcome Measure Information:
Title
Evaluation of clinical improvement
Description
By neurological evaluation (Ranking Scale)
Time Frame
day 2 through day 25
Secondary Outcome Measure Information:
Title
Evaluation of the reduction of the extent of edema lesion documented by MRI
Description
MRI analysis
Time Frame
1-3 months
Title
Measurement of complications from hyperbaric oxygen therapy and their severity
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Adverse Radiation Effects After Gamma Knife Radio Surgery and Hyperbaric Oxygen Therapy
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