NCT01606644

Brief Summary

Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue injury to salivary gland tissue.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 28, 2012

Status Verified

May 1, 2012

Enrollment Period

3.9 years

First QC Date

May 6, 2010

Last Update Submit

May 25, 2012

Conditions

Late Effect of Radiation

Keywords

radiation sequelaehyperbaric oxygen

Outcome Measures

Primary Outcomes (1)

  • Salivation rate

    6 months

Secondary Outcomes (2)

  • Quality of life

    6 months

  • Xerostomia

    6 months

Study Arms (2)

HBO

EXPERIMENTAL

30 90-minute hyperbaric oxygen sessions at 2.4 atm.

Procedure: Hyperbaric oxygen

No HBO

NO INTERVENTION

No intervention. No hyperbaric oxygen is administered. Otherwise, the patient will follow the examination program.

Interventions

Hyperbaric oxygenPROCEDURE

Inhalation of 100% oxygen for 90 minutes

HBO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Head and neck cancer with planned radiation therapy
  • Age \> 18 years

You may not qualify if:

  • Surgical treatment of head and neck cancer
  • Salivary gland disease
  • Severe claustrophobia
  • Pregnancy or lactation (fertile women must use safe contraceptives)
  • Uncontrolled hypertension (\> 220/110)
  • Epilepsy
  • Lack of ability to equalize inner ear pressure
  • Pneumothorax
  • Thoracic surgery within one month before HBO treatment
  • Abuse of alcohol, drugs or narcotics
  • Exposed titanium surfaces or defect titanium in the oral cavity
  • Previous HBO treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia and Department of Oral and Maxillofacial Surgery, Copenhagen University Hospital

Copenhagen, DK-2100, Denmark

RECRUITING

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Lone Forner, DDS, PhD

    Copenhagen University Hospital at Herlev

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lone Forner, DDS, PhD

CONTACT

+45 3545 8211lone.forner@rh.regionh.dk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DDS, PhD

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 28, 2012

Study Start

May 1, 2010

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 28, 2012

Record last verified: 2012-05

Locations

DK(1)