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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05404308
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Francois Baclesse
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Paramedical Consultation, Radiotherapy, Proton Therapy, Brain Tumor
Arms & Interventions

Arms

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

Active Comparator: Standard weekly follow-up by the radiotherapist only

Interventions

Other: - Consultation with Manipulator in Medical Radiology and a radiotherapist

Weekly consultation with Manipulator in Medical Radiology and a radiotherapist

Other: - Consultation with a radiotherapist

Weekly consultation with a radiotherapist

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre François Baclesse, Caen, France

Status

Recruiting

Address

Centre François Baclesse

Caen, , 14076

Site Contact

Magali MICAUD, Ms

[email protected]

+33 2 31 45 51 57

Stay Informed & Connected