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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02714465
Recruitment Status : Recruiting
First Posted : March 21, 2016
Last Update Posted : June 27, 2018
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Cerebral Necrosis Other: hyperbaric oxygen therapy Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
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)
Study Start Date : March 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: 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

Primary Outcome Measures :
  1. Evaluation of clinical improvement [ Time Frame: day 2 through day 25 ]
    By neurological evaluation (Ranking Scale)

Secondary Outcome Measures :
  1. Evaluation of the reduction of the extent of edema lesion documented by MRI [ Time Frame: 1-3 months ]
    MRI analysis

  2. Measurement of complications from hyperbaric oxygen therapy and their severity [ Time Frame: through study completion, an average of 1 year ]

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Ages Eligible for Study:   10 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02714465

ASST Grande Ospedale Metropolitano Niguarda Recruiting
Milano, Lombardia, Italy, 20162
Contact: Simonetta Passarani, MD    +39 02 6444 ext 4637   
Contact: Alessandro la Camera, MD    +30 02 6444 ext 4880   
Sponsors and Collaborators
Niguarda Hospital

Responsible Party: Niguarda Hospital Identifier: NCT02714465     History of Changes
Other Study ID Numbers: 644-122015
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

Keywords provided by Niguarda Hospital:
Hyperbaric Oxygen Therapy; Gamma Knife Radiosurgery

Additional relevant MeSH terms:
Pathologic Processes