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Hyperbaric Radiation Sensitization of Head and Neck Cancers

NCT03843671 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2019-02-18

No results posted yet for this study

Summary

There is reason to believe that hyperbaric oxygen administered immediately prior to radiotherapy will prove beneficial for this cancer type and stage. The basis for this hypothesis is a review of several decades of published work, the conclusion of a recent (2018) Cochrane Review, and results of a Phase I trial.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Hyperbaric oxygen

Hyperbaric oxygen therapy

DEVICE

Hyperbaric chamber

Hyperbaric chamber

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    collaborator OTHER

  • CISSS de Chaudière-Appalaches

    collaborator OTHER_GOV

  • Memorial Hermann Hospital

    collaborator OTHER

  • David Grant U.S. Air Force Medical Center

    collaborator FED

  • 59th Medical Wing

    collaborator FED

  • Prisma Health Richland Hospital

    collaborator UNKNOWN

  • William Jennings Bryan Dorn VA Medical Center

    collaborator FED

  • National Baromedical Services

    lead OTHER

Principal Investigators

  • Richard E Clarke · National Baromedical Services

  • James R Hussey, PhD · University of South Carolina School of Public Health

  • James Wells, MD · Dorn Veterans Medical Center

  • Lindsie Cone, MD · Prisma Health Richland Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2022-12-31
Completion
2024-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03843671 on ClinicalTrials.gov