Paramedical ConsultationMERMOSENCT05404308
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
A study testing Consultation with Manipulator in Medical Radiology and a radiotherapist and Consultation with a radiotherapist in people with Paramedical Consultation and Radiotherapy, run by Centre Francois Baclesse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paramedical Consultation, Radiotherapy, Proton Therapy
- What is being tested?
- Consultation with Manipulator in Medical Radiology and a radiotherapist and Consultation with a radiotherapist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2023to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Paramedical Consultation, Radiotherapy, Proton Therapy, Brain Tumor
- Being tested
- Consultation with Manipulator in Medical Radiology and a radiotherapist, Consultation with a radiotherapist
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consultation with Manipulator in Medical Radiology and a radiotherapistOther
Weekly consultation with Manipulator in Medical Radiology and a radiotherapist
Consultation with a radiotherapistOther
Weekly consultation with a radiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Weekly follow-up by a medical radiography technician and weekly follow-up by the radiotherapist | Experimental | Not described Receives: Other: Consultation with Manipulator in Medical Radiology and a radiotherapist |
| Standard weekly follow-up by the radiotherapist only | Active comparator | Not described Receives: Other: Consultation with a radiotherapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with at least one toxicity requiring intervention
Measured: 3 weeks
Secondary outcomes (1)
Number of toxicities detected
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start17 May 2023
- Primary completionApr 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paramedical ConsultationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized trial
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404308
- Sponsor's protocol ID
- 2021-A00499-32
- Acronym
- MERMOSE
- Status last verified
- Sep 2025
- First submitted
- 31 May 2022
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05404308
- Acronym / sponsor ID
- MERMOSE / 2021-A00499-32
- Conditions
- Paramedical Consultation, Radiotherapy, Proton Therapy, Brain Tumor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized trial
| Arm | Type | Receives |
|---|---|---|
| Weekly follow-up by a medical radiography technician and weekly follow-up by the radiotherapist | Experimental | Other: Consultation with Manipulator in Medical Radiology and a radiotherapist |
| Standard weekly follow-up by the radiotherapist only | Active comparator | Other: Consultation with a radiotherapist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consultation with Manipulator in Medical Radiology and a radiotherapistWeekly consultation with Manipulator in Medical Radiology and a radiotherapist | Other | Weekly follow-up by a medical radiography technician and weekly follow-up by the radiotherapist |
| Consultation with a radiotherapistWeekly consultation with a radiotherapist | Other | Standard weekly follow-up by the radiotherapist only |
Primary outcome
Proportion of patients with at least one toxicity requiring intervention
Time frame: 3 weeks
1 secondary outcome
Number of toxicities detected
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consultation with Manipulator in Medical Radiology and a radiotherapist and Consultation with a radiotherapist in people with Paramedical Consultation and Radiotherapy, run by Centre Francois Baclesse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with at least one toxicity requiring intervention (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.