Esophageal CancerTROS-7NCT06037902
CPAP for Esophageal Cancer With Radiotherapy
A study testing CPAP in people with Esophageal Cancer, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The goal of this clinical trial is to test the use of CPAP in patients with esophgaeal cancer undergoing radiotherapy. The main questions it aims to answer are: does use of CPAP decrease exposure of normal lung to radiation? does use of CPAP decrease exposure of normal heart to radiation? Participants will undergo… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Aug 2023to 30 Sep 2027
- 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
- Diagnosis of cancer, with a tumor (primary or secondary) in the esophagus including tumors in the esophagus-stomach junction.
- Age ≥ 18
- Planned RT treatment
- The level of functioning ≥ 60 on the Karnofsky scale
- Life expectancy ≥ two months
- All patients must understand the informed consent form document and sign it of their own free will before any test/procedure related to the study is performed.
- Able to undergo simulation and radiation with CPAP
- Candidate patients can be recruited to receive definitive, palliative or pre-operative radiation, with or without chemotherapy.
Who cannot join
- A person who meets any of the following exclusion criteria will not be able to participate in the study:
- Pregnancy or breastfeeding
- Significant comorbidity at the starting point that would prevent the use of CPAP
- Hospitalized in an institution by virtue of an administrative order or a court order.
- Special population
- A history of a psychiatric problem that may impair the patient's ability to understand the research requirements or respond to them, or to give his consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 52621
Yaacov R Lawrence, MBBS MA MRCP, 97235304410, Yaacov.Lawrence@sheba.health.gov.il
Aliza Ackerstein, 035308402, aliza.ackerstein@sheba.health.gov.il
About this study
Official title: Use of CPAP (Continuous Positive Airway Pressure) for Simulating Esophageal Cancer Patients Prior to Radiotherapy
The goal of this clinical trial is to test the use of CPAP in patients with esophgaeal cancer undergoing radiotherapy.
The main questions it aims to answer are:
- does use of CPAP decrease exposure of normal lung to radiation?
- does use of CPAP decrease exposure of normal heart to radiation?
Participants will undergo simulation twice:
- with CPAP
- without CPAP
- Conditions
- Esophageal Cancer
- Being tested
- CPAP
- Keywords
- radiation
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
patients undergo simulation twice, with and without CPAP
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | patients will undergo simulation twice, with and without CPAP Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute mean heart radiation dose
measured in Gy
Measured: on day of simulation (day 1)
Secondary outcomes (3)
lung dose in Gy
mean lung dose, V5 and V20
Measured: on day of simulation (day 1)
heart dose in Gy
mean heart dose, V30
Measured: on day of simulation (day 1)
movement of tumor in cm
how much tumor moves with breathing
Measured: on day of simulation (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start21 Aug 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Sheba 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
- Not applicable
- Intervention model
- Single group
- Model description
- all patients undergo two simulations.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Yaacov Lawrence, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037902
- Sponsor's protocol ID
- SHEBA-22-0032-YL-CTIL
- Acronym
- TROS-7
- Status last verified
- Aug 2023
- First submitted
- 28 Aug 2023
- Last updated
- 14 Sep 2023
- 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 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of CPAP (Continuous Positive Airway Pressure) for Simulating Esophageal Cancer Patients Prior to Radiotherapy
- ClinicalTrials.gov ID
- NCT06037902
- Acronym / sponsor ID
- TROS-7 / SHEBA-22-0032-YL-CTIL
- Conditions
- Esophageal Cancer
- Keywords
- radiation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 Sep 2023 (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 clinical trial is to test the use of CPAP in patients with esophgaeal cancer undergoing radiotherapy.
The main questions it aims to answer are:
- does use of CPAP decrease exposure of normal lung to radiation?
- does use of CPAP decrease exposure of normal heart to radiation?
Participants will undergo simulation twice:
- with CPAP
- without CPAP
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all patients undergo two simulations.
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: CPAPpatients will undergo simulation twice, with and without CPAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of cancer, with a tumor (primary or secondary) in the esophagus including tumors in the esophagus-stomach junction.
- Age ≥ 18
- Planned RT treatment
- The level of functioning ≥ 60 on the Karnofsky scale
- Life expectancy ≥ two months
Key exclusion criteria (6 listed)
- A person who meets any of the following exclusion criteria will not be able to participate in the study:
- Pregnancy or breastfeeding
- Significant comorbidity at the starting point that would prevent the use of CPAP
- Hospitalized in an institution by virtue of an administrative order or a court order.
- Special population
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 |
|---|---|---|
| CPAPpatients undergo simulation twice, with and without CPAP | Device | CPAP |
Primary outcome
absolute mean heart radiation dose
Time frame: on day of simulation (day 1)
measured in Gy
3 secondary outcomes
lung dose in Gy
Time frame: on day of simulation (day 1)
heart dose in Gy
Time frame: on day of simulation (day 1)
movement of tumor in cm
Time frame: on day of simulation (day 1)
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 14 Sep 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Esophageal Cancer, run by Sheba Medical Center at 1 site in Israel.
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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Sep 2023. 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 Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absolute mean heart radiation dose (time frame: on day of simulation (day 1)). 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 14 Sep 2023.