Treatment of Cancer in the head and Neck: The Role of Hyperbaric Oxygen in Reducing Swallowing Problems

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001416-27-NL

Enrollment

Registered

2012-06-29

Start date

2012-11-15

Completion date

Unknown

Last updated

2012-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharynx, Oropharynx, Oral Cavity, Hypopharynx, Larynx

Interventions

Trade Name: Conoxia Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with histological proof of SCC of the oropharynx, oral cavity, nasopharynx, hypopharynx and larynx Karnofsky score of 70 or higher Age > 17 years Written informed consent given prior to start of the treatment protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Palliative treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: Potential benefit of prophylactic HBOT in terms of reducing / limiting the amount of dysphagia and / or xerostomia for tumors in the head and neck;Secondary Objective: (Local) Regional control, (Overall) Survival;Primary end point(s): Quality of Life data (EORTC H&N35 questionaire);Timepoint(s) of evaluation of this end point: Start, end treatment, 3,6,12,18,24 months after treatment	—

Measure

Time frame

Main Objective: Potential benefit of prophylactic HBOT in terms of reducing / limiting the amount of dysphagia and / or xerostomia for tumors in the head and neck;Secondary Objective: (Local) Regional control, (Overall) Survival;Primary end point(s): Quality of Life data (EORTC H&N35 questionaire);Timepoint(s) of evaluation of this end point: Start, end treatment, 3,6,12,18,24 months after treatment

—

Secondary

Measure	Time frame
Secondary end point(s): The actuarial Local-Regional Control (LRC) rate, Disease Free Survival (DFS), and Overall Survival (OS) rates will be calculated.;Timepoint(s) of evaluation of this end point: After 4 years	—

Countries

Netherlands

Contacts

Public ContactHead of Radiotherapy

Erasmus MC

31107041491

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026