NCT06687200

Assessing the Ompact of Neutral Pelvic Positioning on Bone Repositioning Quality in Pelvic Radiotherapy Patients

Evaluation of the Interest of a "Neutral Pelvic Positioning" on the Quality of Bone Repositioning in Patients Receiving Pelvic Radiotherapy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study explores whether achieving a neutral pelvic position improves bone repositioning quality for patients undergoing pelvic radiotherapy. While Intensity-Modulated Radiotherapy (IMRT) and Image-Guided Radiotherapy (IGRT) have enhanced target volume precision and reduced side effects, effective patient positioning remains crucial. However, rotational adjustments are limited without a specialized robotic table. Current immobilization devices, customizable or not, show limited impact on positioning accuracy, with mixed results on the use of knee and foot supports. A pilot study identified significant rotational variation, and to address this, a "glute bridge" maneuver is proposed to ensure a neutral pelvic position. This randomized study will evaluate the impact of this maneuver on positioning quality when combined with immobilization and skin markers.

Detailed description

Radiotherapy (RT) is an integral part of curative treatment for pelvic cancers. Intensity-Modulated Radiotherapy (IMRT) has demonstrated benefits in target volume (TV) coverage and sparing healthy tissues. IMRT achieves a highly conformal dose distribution, with steep dose gradients between the TVs and Organs at Risk (OARs). However, its effectiveness depends on the quality of patient repositioning, ensured through positioning imaging, immobilization devices, and skin markers. Image-Guided Radiotherapy (IGRT) involves using imaging systems to verify the correct positioning of the patient, TVs, and OARs. IGRT has shown substantial benefits in enhancing treatment precision and reducing side effects. Translational adjustments can be applied before treatment, but, except for TomoTherapy®, which can correct roll, other rotations (pitch and yaw) require a 6D robotic table, a technology that is not widely available and limited to 3°. The immobilization systems available and used in RT departments vary widely, classified into customizable and non-customizable systems. Two publications have shown that using a customizable immobilization system does not improve bone repositioning in these patients. Two teams have compared non-customizable immobilizations consisting of a knee support alone or combined with a foot support. The team of Cartal et al. (2015) found no significant difference in translations. However, using a knee support alone significantly reduced rotations over 3°. Laaksomaa et al. found no difference in performance between the two setups. A pilot study in our department with 32 patients and nearly 700 images revealed an RX rotation greater than 3° in 19% of the images on average, ranging from 0% to 75% of the positioning images affected by an RX rotation over 3°. These patients were positioned supine with a knee support according to Cartal et al. Data, with a headrest or arm support added if lomboaortic irradiation was needed. Accessories were indexed, and their positions marked during the planning CT for reproducibility across sessions, with skin markers as additional setup aids. Physical therapists recommend a maneuver called the "glute bridge," where patients bend their legs and lift their pelvis three times before straightening their legs without voluntary movement. For the study, the legs will rest on a reproducibly positioned knee support. This maneuver ensures a neutral pelvic position for each patient, relieving contractures in the lumbopelvic region. The "neutral zone" or "balance point theory," as defined by physiology and biomechanics, describes a state that relieves contractures in the lumbopelvic region and ensures balanced baseline tension across muscle groups. The pelvis lift creates co-contraction of the hamstrings, quadriceps, abdominals, and lumbar spinal muscles, promoting this balance. In this randomized study, we propose evaluating the benefit of a neutral pelvic positioning setup achieved by the patient, in addition to immobilization devices and skin markers, on the quality of bone repositioning.

Conditions

• Radiotherapy
• Repositonning Pelvic
• Neutral Pelvic Positioning

Interventions

Type	Name	Description
OTHER	Setup with neutral pelvic positioning technique	Setup with neutral pelvic positioning technique (from dosimetry onward and at each session) and daily IGRT (CBCT or MVCT Mega Voltage Computed Tomography)
OTHER	Standard setup	Standard setup (from dosimetry onward and at each session) and daily IGRT (CBCT or MVCT)

Timeline

• Start date: 2024-11-15
• Primary completion: 2027-02-15
• Completion: 2027-03-01
• First posted: 2024-11-13
• Last updated: 2024-11-13

Locations

4 sites across 1 country: France