NeoplasmsRTCOMFORTNCT06903507
Increasing Patient Comfort in Palliative Radiotherapy With a Newly Developed Mattress - A Prospective Clinical Study
A study testing RT-Comfort Mattress in people with Neoplasms, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The goal of this research is to determine if a new radiotherapy mattress is more comfortable for patients than the standard mattress. The table of the CT scanner and the radiation machine is flat and hard. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- RT-Comfort Mattress
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Aug 2023to 7 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: ≥ 16
- Patients treated for bone metastasis in thoracic, abdominal and pelvic region
- Patients have read, understood and signed the informed consent of the COMFORT study (in Dutch).
Who cannot join
- Patients not willing or able to test two mattresses (RT-Comfort Mattress and standard thin foam matt)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus MC Cancer Institute
Rotterdam, South Holland, Postbus 2040 / 3000 CA
About this study
Official title: The Comfort Study: Determining the Most Comfortable Radiotherapy Mattress
The goal of this research is to determine if a new radiotherapy mattress is more comfortable for patients than the standard mattress. The table of the CT scanner and the radiation machine is flat and hard. To increase comfort during the CT scan and radiation dose delivery, the investigators have recently developed a new mattress (RTComfort). This research aims to find out if the new mattress is more comfortable for patients than the standard matt and to learn how radiotherapy mattresses can be further improved.
Patients who participate in the research, will be asked to try both the standard mattress and the new mattress during the CT scan appointment. This will take about 5 minutes (one minute each). Patients will then be asked which mattress was most comfortable and if they experience any pain while lying on the mattress. Patients can choose which mattress will be used for the CT scan and treatment. Both mattresses are approved and safe for treatment. If patients participate in the research, it means the investigators will collect and use some of their (medical) data.
Patients will not have any direct benefits from participating in this research, except that they can choose which mattress they want to lie on. Additionally, participation can help us gain more knowledge to make radiotherapy treatment more comfortable. Participation in the research will not affect the treatment. Participants will receive the normal treatment and check-ups for their condition. The drawback of participating is that the investigators will ask patients to try both mattresses, which will take about 5 minutes.
- Conditions
- Neoplasms
- Being tested
- RT-Comfort Mattress
- Keywords
- radiotherapy, palliative radiotherapy, radiation oncology, comfort, pain, mattress, bone metastasis
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-Comfort MattressDevice
This dedicated RT-Comfort Mattress was newly developed (patent pending) for increasing comfort without compromising radiotherapy treatment quality.
| Study group | Role | What they receive |
|---|---|---|
| RT-Comfort Mattress | Experimental | In this arm, the RT-Comfort Mattress was applied on top of the flat and hard radiotherapy treatment couch during planning CT acquisition and treatment dose delivery. Receives: Device: RT-Comfort Mattress |
| Standard thin foam matt | No intervention | For patients with painful bone metastasis, a standard thin foam matt is typically added on top of the flat and hard radiotherapy treatment couch to somewhat relief the pain. Unfortunately, this existing matt is too thin to effectively counter discomfort and pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients that prefered the newly developed comfort mattress over the standard thin foam matt
The included patients tested the RT-Comfort Mattress and standard thin foam matt by lying on each for one minute in radiotherapy position, on the flat and hard CT scanner couch. Next, after patients identified their mattress or matt of choice, the treatment preparation and delivery were performed on their mattress or matt of choice according to standard clinical practice.
Measured: Prior to radiotherapy planning-CT acquisition.
Secondary outcomes (4)
The level preferrence of patients for the mattress of choice.
The included patients tested the regular matt and the RT-Comfort Mattress by lying on each for one minute in radiotherapy position, on the flat and hard CT scanner couch. Next, they identified their mattress of choice, and the level of preference; slight or strong.
Measured: Prior to radiotherapy planning-CT acquisition.
The pain patients experienced while lying on the comfort mattress and the standard thin foam matt, according to the 11-point Numerical Rating Scale (NRS).
The 11-point NRS ranges from 0 (equivalent to no pain) to 10 (the worst pain imaginable).
Measured: Prior to radiotherapy planning-CT acquisition, while lying on each mattress for one minute in treatment position.
The positioning stability of patients on the comfort mattress and the standard thin foam matt, measured with optical surface scanning
The positioning stability on the mattress was considered sufficient if two requirements were met; (1) the sagging (i.e.: the change in vertical position over time) during the first 5 minutes of dose delivery should be less than 1 mm averaged over all patients, (2) the variation in vertical position over time should not be larger compared to patients positioned during treatment on the standard matt.
Measured: During the first treatment fraction, the patients' surface scanning measurements were started directly after CBCT positioning verification and stopped directly after treatment dose delivery.
The dosimetrical effect of the RT-Comfort Mattress in the beam
As negligible dosimetric effect was expected, the original treatment plan was generated in the treatment planning system without taking the RT-Comfort mattress in account. To investigate the expected negligible effect of the mattress attenuation on 95% dose coverage of the planning target volume (PTV) and maximum skin dose, the treatment plans were recalculated and reoptimized while accounting for the RT-Comfort mattress using the same treatment planning system. The skin contour was defined as the outer 5-mm of the patient body contour for all CT-slices that included a PTV contour. The PTV itself was excluded from the skin structure.
Measured: The dosimetrical effect was evaluated immediately after the radiotherapy treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start3 Aug 2023
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Health Foam
- Responsible party
- Principal investigator, Steven Petit, Erasmus Medical Center
- Investigators
- Remi Nout, Proffessor, Study director, Erasmus MC Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903507
- Sponsor's protocol ID
- MEC-2023-0295
- Acronym
- RTCOMFORT
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the IRB approved study protocol, collected data will not be exchanged, shared or transferred outside the Erasmus MC. All data is handled conform the Dutch Act on Implementation of the General Data Protection Regulation (in Dutch: Uitvoeringswet Algemene Verordening Gegevensbescherming (UAVG)) and the Erasmus MC privacy regulations. For sharing of data with other parties patients need to be informed and they should agree for that as part of the informed consent procedure. The patients included in this study did not provide written informed consent for sharing of their data with other parties as data sharing with others was not included in the patient information folder.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comfort Study: Determining the Most Comfortable Radiotherapy Mattress
- ClinicalTrials.gov ID
- NCT06903507
- Acronym / sponsor ID
- RTCOMFORT / MEC-2023-0295
- Conditions
- Neoplasms
- Keywords
- radiotherapy, palliative radiotherapy, radiation oncology, comfort, pain, mattress, bone metastasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Royal Health Foam
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 30 Mar 2025 (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.
The goal of this research is to determine if a new radiotherapy mattress is more comfortable for patients than the standard mattress. The table of the CT scanner and the radiation machine is flat and hard. To increase comfort during the CT scan and radiation dose delivery, the investigators have recently developed a new mattress (RTComfort). This research aims to find out if the new mattress is more comfortable for patients than the standard matt and to learn how radiotherapy mattresses can be further improved.
Patients who participate in the research, will be asked to try both the standard mattress and the new mattress during the CT scan appointment. This will take about 5 minutes (one minute each). Patients will then be asked which mattress was most comfortable and if they experience any pain while lying on the mattress. Patients can choose which mattress will be used for the CT scan and treatment. Both mattresses are approved and safe for treatment. If patients participate in the research, it means the investigators will collect and use some of their (medical) data.
Patients will not have any direct benefits from participating in this research, except that they can choose which mattress they want to lie on. Additionally, participation can help us gain more knowledge to make radiotherapy treatment more comfortable. Participation in the research will not affect the treatment. Participants will receive the normal treatment and check-ups for their condition. The drawback of participating is that the investigators will ask patients to try both mattresses, which will take about 5 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT-Comfort Mattress | Experimental | Device: RT-Comfort MattressIn this arm, the RT-Comfort Mattress was applied on top of the flat and hard radiotherapy treatment couch during planning CT acquisition and treatment dose delivery. |
| Standard thin foam matt | No intervention | –For patients with painful bone metastasis, a standard thin foam matt is typically added on top of the flat and hard radiotherapy treatment couch to somewhat relief the pain. Unfortunately, this existing matt is too thin to effectively counter discomfort and pain. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age: ≥ 16
- Patients treated for bone metastasis in thoracic, abdominal and pelvic region
- Patients have read, understood and signed the informed consent of the COMFORT study (in Dutch).
Key exclusion criteria (1 listed)
- Patients not willing or able to test two mattresses (RT-Comfort Mattress and standard thin foam matt)
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 |
|---|---|---|
| RT-Comfort MattressThis dedicated RT-Comfort Mattress was newly developed (patent pending) for increasing comfort without compromising radiotherapy treatment quality. | Device | RT-Comfort Mattress |
Primary outcome
The percentage of patients that prefered the newly developed comfort mattress over the standard thin foam matt
Time frame: Prior to radiotherapy planning-CT acquisition.
The included patients tested the RT-Comfort Mattress and standard thin foam matt by lying on each for one minute in radiotherapy position, on the flat and hard CT scanner couch. Next, after patients identified their mattress or matt of choice, the treatment preparation and delivery were performed on their mattress or matt of choice according to standard clinical practice.
4 secondary outcomes
The level preferrence of patients for the mattress of choice.
Time frame: Prior to radiotherapy planning-CT acquisition.
The pain patients experienced while lying on the comfort mattress and the standard thin foam matt, according to the 11-point Numerical Rating Scale (NRS).
Time frame: Prior to radiotherapy planning-CT acquisition, while lying on each mattress for one minute in treatment position.
The positioning stability of patients on the comfort mattress and the standard thin foam matt, measured with optical surface scanning
Time frame: During the first treatment fraction, the patients' surface scanning measurements were started directly after CBCT positioning verification and stopped directly after treatment dose delivery.
The dosimetrical effect of the RT-Comfort Mattress in the beam
Time frame: The dosimetrical effect was evaluated immediately after the radiotherapy treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No. According to the IRB approved study protocol, collected data will not be exchanged, shared or transferred outside the Erasmus MC. All data is handled conform the Dutch Act on Implementation of the General Data Protection Regulation (in Dutch: Uitvoeringswet Algemene Verordening Gegevensbescherming (UAVG)) and the Erasmus MC privacy regulations. For sharing of data with other parties patients need to be informed and they should agree for that as part of the informed consent procedure. The patients included in this study did not provide written informed consent for sharing of their data with other parties as data sharing with others was not included in the patient information folder.
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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.
Remi Nout, Proffessor study director
Erasmus MC Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RT-Comfort Mattress in people with Neoplasms, run by Erasmus Medical Center at 1 site in Netherlands.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 30 Mar 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The percentage of patients that prefered the newly developed comfort mattress over the standard thin foam matt (time frame: Prior to radiotherapy planning-CT acquisition.). 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 30 Mar 2025.