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

Brain Tumor Clinical Trial

— MERMOSE  

Official title:

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: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05404308
• Other study ID #: 2021-A00499-32
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2023
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: Centre Francois Baclesse
• Contact: Magali MICAUD, Ms
• Phone: +33 2 31 45 51 57
• Email: MICAU[@]baclesse.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: July 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Proton Therapy
• Radiotherapy

Intervention

Other:
• Consultation with Manipulator in Medical Radiology and a radiotherapist
Weekly consultation with Manipulator in Medical Radiology and a radiotherapist
• Consultation with a radiotherapist
Weekly consultation with a radiotherapist

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with at least one toxicity requiring intervention		3 weeks
Secondary	Number of toxicities detected		3 weeks