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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02122042
Other study ID # 64/14
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received April 22, 2014
Last updated April 22, 2014
Start date May 2014

Study information

Verified date April 2014
Source Assaf-Harofeh Medical Center
Contact Amir Hadanny, MD
Phone 972544707381
Email amir.had@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The aim of the current study is to evaluate, in a prospective cross-over, randomized study, the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic impairment after low grade glioma tumor removal surgery


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 62
Est. completion date
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Post low grade glioma (WHO I-II) removal surgery 3-12 months prior to the inclusion in the study.

- All patients have to have persistent cognitive impairment (Mindstream score should be at least one SD lower than average) regarding without noticeable improvement during the last month prior to their enrolment.

- Age 18 years or older.

Exclusion Criteria:

- Dynamic neurologic/cognitive improvement or worsening during the past month; Previous brain radiotherapy and/or radiosurgery. Steroids dependence Chemotherapy in the past month or scheduled in the next 3 months Seizures 1 month previous to inclusion Had been treated with HBOT for any other reason 1 month prior to inclusion; Have any other indication for HBOT; Chest pathology incompatible with pressure changes; Inner ear disease; Patients suffering from claustrophobia; Inability to sign written informed consent; Smoking patients will not be allowed to smoke during the study and if they would not comply with this demand they will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Biological:
HBOT


Locations

Country Name City State
Israel Assaf-Harofeh Medical Center Zerifin

Sponsors (1)

Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neurocognitive functions Cognitive function will be assessed using the one-hour Mindstreams Computerized Cognitive Test Battery at baseline, 3 months and 6 months to intervention. 6 months No
Secondary Quality of Life Quality of live will be evaluated by the EQ-5D,SS-QOL ? SF36 , QLQ-BN20, questionnaires at baseline , 3 months and 6 months to intervention. 6 months No
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