Radiotherapy In a Sitting Position for Enhanced Reproducibility

NCT07887048 | Not Yet Recruiting

• 1 other identifier: ET26-063 (RISE R)
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Head & Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the end of follow up at 8 months

Secondary Outcomes (13)

• Proportion of patients with all the measurements below 3 mm in each anatomical subregion

  From enrollment to the end of follow up at 8 months

• Variability of the inter fraction motion (quantitative values) measured at each setup

  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

  From enrollment to the end of follow up at 8 months

• Likert scale about satisfaction and comfort in both positions.

  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.

  From enrollment to the end of follow up at 8 months

Study Arms (1)

Standard radiation therapy in supine position and simulation in sitting position

EXPERIMENTAL

Radiation: Simulation of radiotherapy session in sitting position

Interventions

Simulation of radiotherapy session in sitting position RADIATION

Simulation of dosimetry and radiotherapy session in sitting position. Radiation therapy will be perform in supine position and as per standard practices.

Standard radiation therapy in supine position and simulation in sitting position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Sitting Position

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10