Interest of a Weekly Consultation by a Medical Electro Radiology Manipulator (MERM) in Addition to the Follow-up by the Radiotherapist to Improve the Collection of Radio-induced Toxicities in Patients Undergoing Proton Therapy

Not Applicable

Active, not recruiting

• Conditions: Brain Tumor; Radiotherapy; Paramedical Consultation; Proton Therapy
• Interventions: Other: Consultation with Manipulator in Medical Radiology and a radiotherapist; Other: Consultation with a radiotherapist

• Registration Number: NCT05404308
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

To our knowledge, the investigators have not found any scientific article dealing with cooperation between radiation oncologists and medical radiation technologists in the context of monitoring patients undergoing radiotherapy. Cooperation protocols between health professionals are in progress but concern mainly technical procedures (ultrasound, laserthermal sessions).

This study aims to evaluate whether MERMs, after training by physicians, can monitor clinical signs (for usual well-described toxicities) during treatment via a dedicated consultation.

This approach participates in the development of new professions and cooperation protocols between health professionals. This mission of accompaniment on a dedicated time would make it possible to develop the caring role of the medical electroradiology manipulator.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-03
• Study Start: 2023-05-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-05
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Patient > 18 years;
• Patient with malignant or benign brain or upper aerodigestive tract (ADT) tumor candidate for proton therapy;
• WHO score < 2
• Mastery of the French language;
• Patient affiliated with a social security system;
• Signature of informed consent prior to any specific procedure related to the study.

Exclusion Criteria

• Patient with another cancer previously treated with radiation therapy;
• Simultaneous participation in a therapeutic clinical trial;
• Patient deprived of liberty or under guardianship;
• Any associated medical or psychological condition that may compromise the patient's ability to participate in the study
• Patient unable to undergo trial monitoring for geographical, social or psychopathological reasons.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weekly follow-up by a medical radiography technician and weekly follow-up by the radiotherapist	Consultation with Manipulator in Medical Radiology and a radiotherapist	-
Standard weekly follow-up by the radiotherapist only	Consultation with a radiotherapist	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with at least one toxicity requiring intervention	3 weeks

Secondary Outcome Measures

Name	Time	Method
Number of toxicities detected	3 weeks

Trial Locations

Locations (1)

Centre François Baclesse; 🇫🇷 Caen, France