The first objective is to assess which determinants predict swallowing dysfunction after curative (chemo)radiation. We want to determine the possible relationships between the radiation dose distributions in anatomical structures involved in…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Grade 2 or more swallowing dysfunction at 6 months after completion of
(chemo)radiation (according to the RTOG/EORTC system).
Secondary outcome
• Findings of videofluoroscopy.
• Dysphagia, Esophageal Morbidity and Aspiration according to the Common
Terminology Criteria for Adverse Events version 3.0.
• Thickening of the pharyngeal constrictor muscles, the pharyngeal and
laryngeal mucosa on CT-scan
• Health related quality of life (EORTC QLQ-C30 and EORTC QLQ-H&N35)
• Patient-rated swallowing complaints (SWAL-QoL)
Background summary
Swallowing dysfunction after curative (chemo)radiation is a frequently reported
side effect which has a major impact on health related quality of live,
probably even more important than radiation-induced xerostomia.
The results of clinical studies identified a number of possible
pathophysiological mechanisms that contribute to the development of
radiation-induced swallowing dysfunction, which are most likely to result from
fibrosis of the pharyngeal muscles and swelling of the pharyngeal and laryngeal
mucosa. Subsequently, the results of other studies strongly suggest that the
dose distribution in the pharyngeal muscles and laryngeal structures are
significantly associated with the probability of swallowing dysfunction.
Consequently, sparing of these structures could result in reduce the risk on
this important side effect.
Study objective
The first objective is to assess which determinants predict swallowing
dysfunction after curative (chemo)radiation. We want to determine the possible
relationships between the radiation dose distributions in anatomical structures
involved in swallowing and the probability of swallowing dysfunction.
The second objective is to determine which pathophysiological mechanisms are
involved in the development of swallowing dysfunction after (chemo)radiation by
using objective measures, including pre- and post-treatment videofluoroscopy
and CT-scan.
The final objective will be to determine which endpoint regarding swallowing is
the most relevant.
Study design
This is a prospective cohort study
Study burden and risks
Additional investigations for this study will be patient-rated swallowing
complaints, videofluoroscopy findings and thickening of the pharyngeal
constrictor muscles, pharyngeal mucosa and laryngeal mucosa as assessed by CT
of the head and neck region.
The burden of this study will be only minimal. Participating patients will
receive approximately 7 mSv extra radiation dose. However, patients will
receive at least 70000 mSV during radiotherapy treatment. Additional ionizing
radiation exposure due to the CT-scan and videofluoroscopy will therefore be
relatively small. Videofluoroscopy will take approximately 20 minutes, CT-scan
will take 20 minutes and every additional questionnaire will take 5 minutes to
complete.
Postbus 30.001
9700 RB Groningen
Nederland
Postbus 30.001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
- primary head and neck cancer (or lymph node metastases from an unknown primary)
- stage I-IV (UICC staging system 2002)
- no distant metastases
- no postoperative radiotherapy / chemo-radiotherapy
- previously untreated
Exclusion criteria
- distant metastases
- surgery
Design
Recruitment
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 |
|---|---|
| CCMO | NL21049.042.07 |