Primary Study Objectives:This study tries to objectives the potential benefit of prophylactic HBOT in terms of reducing / limiting the amount of dysphagia and / or xerostomia for tumors in the head and neck, specifically originating from the…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of Life of the patients (dysphagia, xerostomia)
Quality of Life
The assessment of QoL will be performed using disease-specific aspects, that is
the Performance Status Scale for Head and Neck cancer (PSSHN) 22. The
performance status scale includes the daily core activities: ability to eat in
public, normalcy of speech, and normalcy of diet. The eating in public subscale
assesses the impact of eating function disturbances on the social integration
of the patient by reporting restrictions of settings and people present during
food intake. The understandability of speech subscale rates the degree to which
the interviewer is able to understand the patient*s speech. The normalcy of
diet subscale assesses the food the patient is able to eat, with categories
spanning the range form normal diet to no-oral feedings. The three subscales
are rated from 0 to 100, with 100 representing normal function.
The EORTC QLQ-C30 and the EORTC QLQ-H&N35 and MDADI questionnaires will also be
used during the protocol to assess the Quality of Life. Finally, the 4 items of
the score card should be scored with every outpatient clinic visit.
Secondary outcome
Tumor Control
The actuarial Local-Regional Control (LRC) rate, Disease Free Survival (DFS),
and Overall Survival (OS) rates will be calculated. Kaplan Meijer Curves will
be generated.
Background summary
Positive pilot study in reducing side-effects after radiation treatment in head
and neck cancer patients.
Study objective
Primary Study Objectives:
This study tries to objectives the potential benefit of prophylactic HBOT in
terms of reducing / limiting the amount of dysphagia and / or xerostomia for
tumors in the head and neck, specifically originating from the nasopharynx and
oropharynx. Moreover, given that patients with tumors in the hypopharynx and
the T3-4 tumors of the larynx also complain of dysphagia and xerostomia,
frequently occurring late side effects, the HBO prophylactic treatment might
also apply to these tumors.
Dysphagia
• Can HBO reduce the amount of RT-induced dysphagia in patients with cancer of
the head and neck?
Xerostomia
• Can HBO reduce the amount of RT-induced xerostomia in cancer of the head and
neck?
Trismus
• Can HBO reduce the amount of surgically and / or RT-induced trismus in cancer
of the head and neck?
Grade 3/4 (WHO) Mucositis
• Can HBO reduce the amount of RT-induced mucositis in cancer of the head and
neck?
Secondary Study Objectives:
• What is the localregional control / (overall) survival in patients with
cancer of the head and neck (standard protocol) with or without HBO
Study design
Included patients will be randomized in receiving yes or no hyperbaric oxygen
treatment.
Intervention
Hyperbaric oxygen treatment.
Study burden and risks
Patients will receiving an additional treatment of hyperbaric oxygen sessiosn
of 30 x 2 hours a day.
Groene Hilledijk 301
Rotterdam 3075EA
NL
Groene Hilledijk 301
Rotterdam 3075EA
NL
Listed location countries
Age
Inclusion criteria
• Patients with histological proof of squamous cell carcinoma of mucous membranes of the oropharynx, oral cavity, nasopharynx, hypophayrnx and larynx to be treated with curative intent
• Karnofsky score of 70 or higher
• Age >= 18 years
• Written informed consent given prior to start of the treatment protocol
Exclusion criteria
Pregnant woman
Heart injection fraction of < 30%
COPD or lungemphysema
Infection in the upper airways
Recent middle ear surgery
Recent thorax surgery
Uncontrolled fever
Severe epilepsia
Carefullness with claustrofobic patients
Carefullnes in patients with a medical history pneumothorax, thorax surgery or epileptic insults,
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 25123615 |
| EudraCT | EUCTR2012-001416-27-NL |
| CCMO | NL39443.078.12 |