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Oxygen Enhancer

NanO2 for Glioblastoma (RESTORE Trial)

Phase 2

Recruiting

Research Sponsored by NuvOx LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years and older.

Histologically confirmed, newly diagnosed primary or secondary glioblastoma multiforme.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 22 months

Awards & highlights

RESTORE Trial Summary

This trial tests a new drug to see if it helps treat cancer when combined with standard treatments.

Who is the study for?

Adults with newly diagnosed glioblastoma who can have MRI scans, have a life expectancy of at least 3 months, and are in good enough health to undergo radiation and chemotherapy. They must not be pregnant or breastfeeding, agree to use effective birth control, and cannot have had any prior treatment for glioblastoma or other significant medical conditions that could interfere with the trial.Check my eligibility

What is being tested?

The trial is testing NanO2TM combined with standard radiation therapy and temozolomide chemotherapy. NanO2TM is designed to increase oxygen delivery to tumors which may enhance the effectiveness of radiation therapy against brain cancer.See study design

What are the potential side effects?

While specific side effects for NanO2TM aren't listed, common side effects from similar treatments include fatigue, headache, nausea, skin irritation from radiation, low blood counts leading to increased infection risk or bleeding tendencies.

RESTORE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been newly diagnosed with glioblastoma.

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My treatment plan includes specific radiation and chemotherapy doses.

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I am able to care for myself but may not be able to do active work.

RESTORE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 22 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~22 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 22 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-Free Survival (PFS)

Secondary outcome measures

Caregiver quality of life

Overall Survival

Patient quality of life

+4 more

RESTORE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NanO2TMExperimental Treatment1 Intervention

NanO2TM infusion in conjunction with Radiation Treatment and temozolomide

Group II: PlaceboPlacebo Group1 Intervention

Placebo Saline infusion in conjunction with Radiation Treatment and temozolomide

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

NuvOx LLCLead Sponsor

4 Previous Clinical Trials

335 Total Patients Enrolled

1 Trials studying Glioblastoma

11 Patients Enrolled for Glioblastoma

Media Library

Glioblastoma Research Study Groups: NanO2TM, Placebo

Glioblastoma Clinical Trial 2023: NanO2TM Highlights & Side Effects. Trial Name: NCT03862430 — Phase 2

NanO2TM (Oxygen Enhancer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03862430 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned NanO2TM for public consumption?

"Our evaluation of NanO2TM's safety was a 2 on the 1-3 scale due to having preliminary data related to its security, but no evidence validating efficacy."

Answered by AI

Has NanO2TM been evaluated in any other experimental studies?

"Currently, there is 1 clinical trial underway researching NanO2TM. None of these trials are currently in the 3rd phase. Despite the majority of studies taking place in Tucson, Arizona, there is an additional research centre running similar tests for this particular treatment."

Answered by AI

What is the upper limit of enrollees in this research trial?

"Affirmative. Clinicaltrials.gov attests to this clinical trial's ongoing recruitment, which began on March 31st 2023 and was modified most recently on March 24th 2023. This study seeks 87 participants from 1 location specifically."

Answered by AI

Does this research endeavor have open enrollment?

"Affirmative. According to the latest information on clinicaltrials.gov, this study is actively recruiting participants since its debut in March 31st 2023 and subsequent update on March 24th 2023. 87 volunteers will be enrolled at a single trial site."

Answered by AI

Is this an innovative medical study?

"Presently, there is one ongoing investigation of NanO2TM in 1 city and nation. Initially launched in 2023 by NuvOx LLC, the trial was attended to completion by 87 participants during its Phase 2 pharmacological approval stage. Since then, only a single study involving NanO2TM has been initiated."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase II Double-blind, RandomizEd, Prospective, Placebo Controlled STudy of NanO2TM Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma multiformE:

2023. "A Phase II Double-blind, RandomizEd, Prospective, Placebo Controlled STudy of NanO2TM Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma multiformE:". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03862430.

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