Active, not recruitingNCT05404308MERMOSEUpdated Sep 17, 2025

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

An interventional study of Consultation with Manipulator in Medical Radiology and a radiotherapist and Consultation with a radiotherapist in Paramedical Consultation, Radiotherapy and Proton Therapy, sponsored by Centre Francois Baclesse. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by Centre Francois Baclesse · Not applicable, Interventional, and Other

From the registry’s dates

Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as active, not recruiting.

Phase: Not applicable
Study type: Interventional
Enrollment: 92
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Paramedical Consultation
Radiotherapy
Proton Therapy
Brain Tumor

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Brain Neoplasms 1,960

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 515 are open to participants now.

This study's planned enrollment of 92 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.

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Lead sponsor

Centre Francois Baclesse is the lead sponsor of 109 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 92 participants (estimated)

Study arms

Experimental
Weekly follow-up by a medical radiography technician and weekly follow-up by the radiotherapist
Other: Consultation with Manipulator in Medical Radiology and a radiotherapist
Active comparator
Standard weekly follow-up by the radiotherapist only
Other: Consultation with a radiotherapist

Interventions

OtherConsultation with Manipulator in Medical Radiology and a radiotherapist
Weekly consultation with Manipulator in Medical Radiology and a radiotherapist
OtherConsultation with a radiotherapist
Weekly consultation with a radiotherapist

What researchers measure

Primary outcomes

Proportion of patients with at least one toxicity requiring intervention
Time frame: 3 weeks

Secondary outcomes

Number of toxicities detected
Time frame: 3 weeks

Study locations

1 site

Centre François Baclesse
Caen, 14076, France

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05404308
Lead sponsor: Centre Francois Baclesse
Responsible party: Sponsor
First posted: Jun 3, 2022
Start date: May 17, 2023
Primary completion: Apr 2026 (estimated)
Completion: Jul 2026 (estimated)
Last update: Sep 17, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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