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

NCT ID: NCT05404308

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-17

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Paramedical Consultation Radiotherapy Proton Therapy Brain Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized trial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Weekly follow-up by a medical radiography technician and weekly follow-up by the radiotherapist

Group Type EXPERIMENTAL

Consultation with Manipulator in Medical Radiology and a radiotherapist

Intervention Type OTHER

Weekly consultation with Manipulator in Medical Radiology and a radiotherapist

Standard weekly follow-up by the radiotherapist only

Group Type ACTIVE_COMPARATOR

Consultation with a radiotherapist

Intervention Type OTHER

Weekly consultation with a radiotherapist

Interventions

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Consultation with Manipulator in Medical Radiology and a radiotherapist

Weekly consultation with Manipulator in Medical Radiology and a radiotherapist

Intervention Type OTHER

Consultation with a radiotherapist

Weekly consultation with a radiotherapist

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre François Baclesse

Caen, , France

Site Status

Countries

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France

Other Identifiers

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2021-A00499-32

Identifier Type: -

Identifier Source: org_study_id

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