Brain Tumor Clinical Trial
— MERMOSEOfficial 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
NCT number | NCT05404308 |
Other study ID # | 2021-A00499-32 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 17, 2023 |
Est. completion date | July 2025 |
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.
Status | Recruiting |
Enrollment | 92 |
Est. completion date | July 2025 |
Est. primary completion date | May 2025 |
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. |
Country | Name | City | State |
---|---|---|---|
France | Centre François Baclesse | Caen |
Lead Sponsor | Collaborator |
---|---|
Centre Francois Baclesse |
France,
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 |
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