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NCT Number: NCT05404308

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Paramedical Consultation Brain Diseases Brain Neoplasms Brain Tumor Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Proton Therapy Radiotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse

Caen, 14076, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Consultation with Manipulator in Medical Radiology and a radiotherapist

Other

Weekly consultation with Manipulator in Medical Radiology and a radiotherapist

Consultation with a radiotherapist

Other

Weekly consultation with a radiotherapist

Primary outcomes

  1. Proportion of patients with at least one toxicity requiring intervention

    Time frame: 3 weeks

Secondary outcomes

  1. Number of toxicities detected

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Official study 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

Acronym: MERMOSE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2022
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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