NCT02714465

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

6.8 years

First QC Date

March 1, 2016

Last Update Submit

March 21, 2023

Conditions

Cerebral Necrosis

Keywords

Hyperbaric Oxygen Therapy; Gamma Knife Radiosurgery

Outcome Measures

Primary Outcomes (1)

  • Evaluation of clinical improvement

    By neurological evaluation (Ranking Scale)

    day 2 through day 25

Secondary Outcomes (2)

  • Evaluation of the reduction of the extent of edema lesion documented by MRI

    1-3 months

  • Measurement of complications from hyperbaric oxygen therapy and their severity

    through study completion, an average of 1 year

Study Arms (1)

Hyperbaric oxygen therapy

EXPERIMENTAL

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

Other: hyperbaric oxygen therapy

Interventions

hyperbaric oxygen therapyOTHER

hyperbaric oxygen therapy

Hyperbaric oxygen therapy

Eligibility Criteria

Age10 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST Grande Ospedale Metropolitano Niguarda

Milan, Lombardy, 20162, Italy

Location

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 21, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

IT(1)