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Hyperbaric Radiation Sensitization of Head and Neck Cancers

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.
 
ClinicalTrials.gov Identifier: NCT03843671
Recruitment Status : Not yet recruiting
First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
Mayo Clinic
Dartmouth-Hitchcock Medical Center
CISSS de Chaudière-Appalaches
Memorial Hermann Hospital
David Grant U.S. Air Force Medical Center
Wilford Hall Medical Center
Prisma Health Richland Hospital
William Jennings Bryan Dorn VA Medical Center
Information provided by (Responsible Party):
National Baromedical Services

Brief 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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Drug: Hyperbaric oxygen Device: Hyperbaric chamber Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized sham-controlled, with allocation concealment and blinded patients and assessors
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Both groups compressed in a hyperbaric chamber. Patients will be unaware of the compression gas or degree of pressurization as references to each are obscured
Primary Purpose: Treatment
Official Title: A Phase II Randomized Sham-Controlled Trial With Allocation Concealment and Blinded Patients and Assessors, Investigating Hyperbaric Oxygen as a Radiation Sensitizer for Locally Advanced Squamous Cell Carcinoma of the Oropharynx and Larynx
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Group 1
Hyperbaric oxygen Hyperbaric chamber
Drug: Hyperbaric oxygen
Hyperbaric oxygen therapy
Other Name: Hyperbaric chamber

Device: Hyperbaric chamber
Hyperbaric chamber

Sham Comparator: Group 2
Sham for hyperbaric oxygen Hyperbaric chamber
Drug: Hyperbaric oxygen
Hyperbaric oxygen therapy
Other Name: Hyperbaric chamber

Device: Hyperbaric chamber
Hyperbaric chamber




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: Two years ]
    Per blinded radiotherapy assessor

  2. Relapse free survival [ Time Frame: Two years ]
    Per blinded radiotherapy assessor


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Two years ]
    Per blinded radiotherapy assessor

  2. Incidence of acute hyperbaric complications; ear/sinus barotrauma, oxygen toxicity, myopia, confinement anxiety [ Time Frame: At seven weeks from start of protocol, having completed 35 hyperbaric chamber exposures ]
    Clinical and study record assessment by hyperbaric physician

  3. Incidence and degree of acute radiation toxicity [ Time Frame: At seven weeks from start of protocol, having completed 35 radiotherapy treatments ]
    Common Terminology Criteria Adverse Events version 5.0

  4. Incidence and degree of late radiation tissue injury [ Time Frame: Two years ]
    Common Terminology Criteria Adverse Events version 5.0 and clinical assessment

  5. Hyperbaric protocol and radiotherapy dosing protocol compliance [ Time Frame: Approximately 45 days after initiation of protocol ]
    Assessed per Radiation Therapy Chair and hyperbaric oxygen physician per medical record review

  6. Subject quality of life: Rating scale [ Time Frame: Two week post RT, then 3, 6, 12 & 24 months post radiotherapy ]
    Functional Assessment of Cancer Therapy: Head and Neck version 4.0 $ Performance Status Scale for Head and Neck.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histological or microscopic proof (from the primary tumor and/or lymph nodes) of invasive squamous cell carcinoma of the oral cavity, oropharynx or larynx (World Health Organization type 1).
  2. Stage III or IV disease, M0
  3. Non-surgical candidate; for reasons of health or age (except biopsy)
  4. Human Papillomavirus (P16) negative
  5. Life expectancy of at least 6 months and a Karnofsky performance status of ≥ 70
  6. Age ≥ 18 years
  7. No distant metastatic disease
  8. No clinically significant heart disease:

    No significant ventricular arrhythmia requiring medication with antiarrhythmic. No symptomatic coronary artery disease (angina). No myocardial infarction within the last 6 months. No second or third degree heart block or bundle branch block or clinically significant conduction system abnormality.

  9. Patients must sign a study-specific informed consent form

Exclusion Criteria:

  1. Histology other than squamous cell carcinoma
  2. Evidence of metastasis (below the clavicle or distant) by clinical or radiographic means
  3. History of prior invasive malignancy, unless at least 5 years without evidence of recurrence (tumor-specific restaging)
  4. Prior resection of the primary tumor or lymph node, unless un-operated N2-N3 nodal disease or primary tumor remaining, respectively.
  5. Prior chemotherapy for head and neck cancer or radiotherapy to the head and neck
  6. Prior treatment with Bleomycin
  7. Creatinine clearance: measured or estimated Glomerular Filtration Rate <40 ml/min.
  8. Patients with simultaneous primaries
  9. Pregnancy
  10. Participating in a conflicting protocol
  11. Pulmonary pathologies (risk of decompression-induced pulmonary barotrauma)

    Current, untreated pneumothorax. Previous history of spontaneous pneumothorax. Previous history of intrathoracic surgery. History or evidence of pulmonary blebs or bullous lung disease. Clinically significant chronic obstructive pulmonary disease, associated with carbon dioxide retention, poorly controlled or associated with acute bronchospasm.

  12. Where the hyperbaric physician deems the patient to have an otherwise unacceptable risk for hyperbaric chamber exposure
  13. Claustrophobia

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 ClinicalTrials.gov identifier (NCT number): NCT03843671


Contacts
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Contact: Richard E Clarke +1.803.434.7101 dick.clarke@palmettohealth.org
Contact: Lindsie Cone, MD +1.803.434.7812 lindsie.Cone@uscmed.sc.edu

Locations
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United States, Minnesota
The Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Robert Foote, MD       foote.robert@mayo.edu   
Principal Investigator: Robert Foote, MD         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Not yet recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Jay Buckey, MD         
Contact       Jay.C.Buckey.Jr@dartmouth.edu   
Principal Investigator: Jay Buckey, MD         
United States, South Carolina
Prisma Health Richland Hospital Not yet recruiting
Columbia, South Carolina, United States, 29203
Contact: Lindsie Cone, MD    803-434-7101    Lindsie.Cone@uscmed.sc.edu   
Principal Investigator: Lindsie Cone, MD         
United States, Texas
Wilford Hall Medical Facility Not yet recruiting
San Antonio, Texas, United States, 78236
Contact: Michael Richards, MD       michael.f.richards4.mil@mail.mil   
Canada, Quebec
Hotel Dieu Hospital of Levis Not yet recruiting
Lévis, Quebec, Canada, G6V 3Z1
Contact: Dominique Buteau, MD         
Sponsors and Collaborators
National Baromedical Services
Mayo Clinic
Dartmouth-Hitchcock Medical Center
CISSS de Chaudière-Appalaches
Memorial Hermann Hospital
David Grant U.S. Air Force Medical Center
Wilford Hall Medical Center
Prisma Health Richland Hospital
William Jennings Bryan Dorn VA Medical Center
Investigators
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Study Chair: Richard E Clarke National Baromedical Services
Principal Investigator: James R Hussey, PhD University of South Carolina School of Public Health
Principal Investigator: James Wells, MD Dorn Veterans Medical Center
Principal Investigator: Lindsie Cone, MD Prisma Health Richland Hospital

Publications:
Bennett M, et al. Hyperbaric Oxygenation for Tumor Sensitization to Radiotherapy. In The Cochrane Library, Issue 1, 2006. Oxford: Update Software. 1-61.
Clarke, RE, et al. Hyperbaric Oxygen as a Radiation Sensitizer for Locally Advanced Squamous Cell Carcinoma of the Head and Neck: A Phase I Dose Escalation Study. J Clinical Oncology 2010;28 (Suppl. Abstract e16002)

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Responsible Party: National Baromedical Services
ClinicalTrials.gov Identifier: NCT03843671     History of Changes
Other Study ID Numbers: NBS2019-1
93840508 ( Registry Identifier: ISRCTN )
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by National Baromedical Services:
Hyperbaric oxygen; HNSCC; Radiotherapy; Chemotherapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site