An interventional study of Simulation of radiotherapy session in sitting position in Head & Neck Cancer, sponsored by Centre Leon Berard. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Centre Leon Berard · Not applicable, Interventional, and Other
Qualitative, longitudinal and single-center study To explore the reproductibility and the acceptability of the sitting position for head and neck cancer patients through their experience of sitting and supine positions in the context of radiation therapy.
Patients will receive their radiation therapy and undergo a dosimetric CT scan as part of standard care.
During their first week of treatment, an initial positioning in the sitting position will be performed. The time required for positioning and repositioning in both the sitting and supine positions will be recorded, as well as the acquisition of the optical reference image.
The second, third, and fourth positioning sessions in the sitting position will take place during the patient's first two weeks of treatment. The setup and take-off times in the supine and sitting positions will be recorded again, and the reproducibility of sitting position will be assessed by comparing it to the reference image. During the radiotherapy simulation in the sitting position, the patient will be seated in a chair. The chair will perform 6 clockwise and counterclockwise rotations over a 21-minute period. Every 3 minutes, the patient's position will be compared to the reference image. Abdominal discomfort in the sitting position will be assessed at each setup. Comfort, satisfaction, level of apprehension, and difficulty swallowing will be assessed at the end of the four setups.
To study the acceptability of sitting position among patients, a focus group will be organized. Patients will join a videoconference using a pseudonym and turn off their cameras. They will be asked questions, and their reactions will be recorded.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's planned enrollment of 16 is below the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Centre Leon Berard is the lead sponsor of 210 studies on the registry; 62 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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1. Patient age ≥ 18 years; 2. Head and/or neck cancer patient treated with radiotherapy; 3.Covered by a medical insurance; 4.Signed and dated informed consent document
Exclusion Criteria:
1. Pregnant women or lactating mother; 2. Patient under guardianship or curatorship; 3. Patient who does not understand or read French; 4. Patient who cannot stand, seat or walk.
Radiation: Simulation of radiotherapy session in sitting position
Simulation of dosimetry and radiotherapy session in sitting position. Radiation therapy will be perform in supine position and as per standard practices.
Proportion of patients with setups performed in sitting position for which all interfraction shifts are below 3 mm in all 3 directions and 3 anatomical subregions
Time frame: From enrollment to the end of follow up at 8 months
Proportion of patients with all the measurements below 3 mm in each anatomical subregion
Time frame: From enrollment to the end of follow up at 8 months
Variability of the inter fraction motion (quantitative values) measured at each setup
Time frame: From enrollment to the end of follow up at 8 months
Variability of the intra fraction motion from optical images during the first 2 weeks for the chin, neck and shoulders over a 21-min period
Time frame: From enrollment to the end of follow up at 8 months
Likert scale about satisfaction and comfort in both positions.
Time frame: From enrollment to the end of follow up at 8 months
Interruption is defined by the number of times where the patient will request to remove the thermoplastic mask during the beam delivery or the treatment simulation.
Time frame: From enrollment to the end of follow up at 8 months
Difference in motion illness symptoms measured before and after upright test based on the motion illiness symptoms classification
Time frame: From enrollment to the end of follow up at 8 months
Difference between the result of the distress thermometer in supine and in sitting position
Time frame: From enrollment to the end of follow up at 8 months
Rate of patients with dysphagia based on the PRO-CTCAE on difficulty swallowing
Time frame: From enrollment to the end of follow up at 8 months
Number of patients who accepted to be setup on the chair and tolerate the simulation of the treatment.
Time frame: From enrollment to the end of follow up at 8 months
Time between the moment when the patient is ready to setup and before acquisition of reference images. (in minutes)
Time frame: From enrollment to the end of follow up at 8 months
Time between the moment when the patient is ready to setup and before images verification (in minutes).
Time frame: From enrollment to the end of follow up at 8 months
Time between the moment when RTT is close to the patient and the patient is in standing position (in minutes).
Time frame: From enrollment to the end of follow up at 8 months
Number of interruptions in supine and sitting position during the beam delivery or the treatment simulation
Time frame: From enrollment to the end of follow up at 8 months
No study locations are listed for this record.
Start is estimated for Dec 2026; primary completion for Aug 2027, 8 months later.
Of 412 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 67. This study's planned 8 months is below that.
Counting every sponsor, half of 427 studies reached it within 34 months; a quarter within 18 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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