Endometrial CancerNCT04318340
A Novel Tapered Applicator for Vaginal Vault Brachytherapy
A study testing Tapered applicator and Standard applicator in people with Endometrial Cancer and Brachytherapy, run by Yale University at 1 site in United States.
Trial summary
This study will assess the comfort and fit of a novel applicator for endometrial cancer patients who are candidates for vaginal brachytherapy. This study is only assessing the applicator fitting. No patients in this study will be treated with the novel applicator. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Brachytherapy, Quality of Life
- What is being tested?
- Tapered applicator and Standard applicator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2020to 20 Mar 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects meeting any of the criteria below may not participate in the study:
- Requires premedication with pain medications and/or anxiolytics during applicator fitting.
- Will receive pelvic EBRT.
- Prior known diagnosis of lupus, scleroderma, dermatomyositis, Crohn's disease, ulcerative colitis, pacemakers, or other contraindications to radiotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Smilow Cancer Hospital
New Haven, Connecticut, 06519
About this study
Official title: A Novel Tapered Applicator for Post-Hysterectomy Vaginal Vault Brachytherapy: Quality-of-Life Assessment of Patient Comfort and In Vivo Dosimetry
This study will assess the comfort and fit of a novel applicator for endometrial cancer patients who are candidates for vaginal brachytherapy. This study is only assessing the applicator fitting. No patients in this study will be treated with the novel applicator.
Read the detailed description
In the treatment of endometrial cancer, adjuvant vaginal brachytherapy is typically performed to deliver radiation dose to the apex of the vagina with a fixed diameter vaginal applicator which extends the full length of the vagina. The largest cylinder which fits at the apex provides the best dosimetry. Smaller diameter cylinders may provide sub-optimal coverage of potential areas of disease. Due to pain or discomfort with a large cylinder, some women may be treated with a smaller diameter cylinder. A novel applicator, with a tapered design and two-step insertion was fabricated to improve the comfort, fit, and patient compliance of this procedure while maintaining optimum geometry and dosimetry at the dome. Our primary aim is to assess patient comfort with the new applicator. Patients will be fit with different applicators (standard of care and novel tapered vaginal applicator) and their comfort will be assessed with a visual analog scale-based survey, comparing the two.
Aim #1: Assess if the 3.0cm diameter novel tapered applicator is more comfortable than the standard 3.0cm diameter applicator among patients fitted with a standard 3.0cm diameter applicator.
Aim #2: Determine what percentage of patients who would otherwise be treated with a standard 2.6cm diameter vaginal cylinder can be up-sized to a 3.0cm diameter cylinder with the novel tapered applicator design.
Aim #3: Assess in vivo dosimetry (optional for all patients). Patients who are prescribed vaginal brachytherapy undergo 3-dimensional cross-sectional imaging (i.e., MRI or CT) prior to treatment, as standard of care. This is done with the standard treatment applicator inserted to assess radiation dose distribution. In this optional aim, patients will undergo a slightly longer MRI, with additional MRI images performed with the novel tapered applicator in place to characterize and assess dosimetry, fit, contact with mucosal surfaces and presence of air gaps in comparison to a standard cylindrical applicator.
- Conditions
- Endometrial Cancer, Brachytherapy, Quality of Life
- Being tested
- Tapered applicator, Standard applicator
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapered applicatorOther
An applicator inserted in 2 steps that tapers at the distal vagina
Standard applicatorOther
A 2.6 cm standard applicator is inserted and sized up to a standard 3 cm applicator if tolerable.
| Study group | Role | What they receive |
|---|---|---|
| Standard Applicators | Active comparator | All patients will be fitted with the 2.6 cm applicator and sized up to the 3.0 cm applicator if tolerable. Receives: Other: Standard applicator |
| Tapered Applicator | Experimental | All patients will be fitted with the novel tapered 3.0 cm applicator. Patients have the option of having magnetic resonance imaging with the tapered applicator in place. Receives: Other: Tapered applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comfort
Patient comfort will be assessed with a visual analog scale-based survey rating 0 (none) to 10 (severe) in each of the following domains: pain, pressure, burning, stress, hardness/roughness, and stretching at both insertion and in final resting positions.
Measured: up to 10 minutes
Ability to up-size with tapered applicator
Determine what percentage of patients who would otherwise be treated with a standard 2.6cm diameter vaginal cylinder can be up-sized to a 3.0cm diameter cylinder with the novel tapered applicator design.
Measured: up to 10 minutes
Secondary outcomes (1)
Assess in vivo dosimetry (optional for all patients)
Patients who are prescribed vaginal brachytherapy undergo 3-dimensional cross-sectional imaging (i.e., MRI or CT) prior to treatment, as standard of care. This is done with the standard treatment applicator inserted to assess radiation dose distribution. In this optional aim, patients will undergo a slightly longer MRI, with additional MRI images performed with the novel tapered applicator in place to characterize and assess dosimetry, fit, contact with mucosal surfaces and presence of air gaps in comparison to a standard cylindrical applicator.
Measured: up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start16 Jul 2020
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shari Damast, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318340
- Sponsor's protocol ID
- 2000026385
- Status last verified
- Jul 2023
- First submitted
- 20 Mar 2020
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Tapered Applicator for Post-Hysterectomy Vaginal Vault Brachytherapy: Quality-of-Life Assessment of Patient Comfort and In Vivo Dosimetry
- ClinicalTrials.gov ID
- NCT04318340
- Acronym / sponsor ID
- 2000026385
- Conditions
- Endometrial Cancer, Brachytherapy, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 23 Mar 2020 (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.
This study will assess the comfort and fit of a novel applicator for endometrial cancer patients who are candidates for vaginal brachytherapy. This study is only assessing the applicator fitting. No patients in this study will be treated with the novel applicator.
Detailed description
In the treatment of endometrial cancer, adjuvant vaginal brachytherapy is typically performed to deliver radiation dose to the apex of the vagina with a fixed diameter vaginal applicator which extends the full length of the vagina. The largest cylinder which fits at the apex provides the best dosimetry. Smaller diameter cylinders may provide sub-optimal coverage of potential areas of disease. Due to pain or discomfort with a large cylinder, some women may be treated with a smaller diameter cylinder. A novel applicator, with a tapered design and two-step insertion was fabricated to improve the comfort, fit, and patient compliance of this procedure while maintaining optimum geometry and dosimetry at the dome. Our primary aim is to assess patient comfort with the new applicator. Patients will be fit with different applicators (standard of care and novel tapered vaginal applicator) and their comfort will be assessed with a visual analog scale-based survey, comparing the two.
Aim #1: Assess if the 3.0cm diameter novel tapered applicator is more comfortable than the standard 3.0cm diameter applicator among patients fitted with a standard 3.0cm diameter applicator.
Aim #2: Determine what percentage of patients who would otherwise be treated with a standard 2.6cm diameter vaginal cylinder can be up-sized to a 3.0cm diameter cylinder with the novel tapered applicator design.
Aim #3: Assess in vivo dosimetry (optional for all patients). Patients who are prescribed vaginal brachytherapy undergo 3-dimensional cross-sectional imaging (i.e., MRI or CT) prior to treatment, as standard of care. This is done with the standard treatment applicator inserted to assess radiation dose distribution. In this optional aim, patients will undergo a slightly longer MRI, with additional MRI images performed with the novel tapered applicator in place to characterize and assess dosimetry, fit, contact with mucosal surfaces and presence of air gaps in comparison to a standard cylindrical applicator.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Applicators | Active comparator | Other: Standard applicatorAll patients will be fitted with the 2.6 cm applicator and sized up to the 3.0 cm applicator if tolerable. |
| Tapered Applicator | Experimental | Other: Tapered applicatorAll patients will be fitted with the novel tapered 3.0 cm applicator. Patients have the option of having magnetic resonance imaging with the tapered applicator in place. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Subjects meeting any of the criteria below may not participate in the study:
- Requires premedication with pain medications and/or anxiolytics during applicator fitting.
- Will receive pelvic EBRT.
- Prior known diagnosis of lupus, scleroderma, dermatomyositis, Crohn's disease, ulcerative colitis, pacemakers, or other contraindications to radiotherapy.
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 |
|---|---|---|
| Tapered applicatorAn applicator inserted in 2 steps that tapers at the distal vagina | Other | Tapered Applicator |
| Standard applicatorA 2.6 cm standard applicator is inserted and sized up to a standard 3 cm applicator if tolerable. | Other | Standard Applicators |
Primary outcome
Patient comfort
Time frame: up to 10 minutes
Patient comfort will be assessed with a visual analog scale-based survey rating 0 (none) to 10 (severe) in each of the following domains: pain, pressure, burning, stress, hardness/roughness, and stretching at both insertion and in final resting positions.
Ability to up-size with tapered applicator
Time frame: up to 10 minutes
Determine what percentage of patients who would otherwise be treated with a standard 2.6cm diameter vaginal cylinder can be up-sized to a 3.0cm diameter cylinder with the novel tapered applicator design.
1 secondary outcome
Assess in vivo dosimetry (optional for all patients)
Time frame: up to 10 minutes
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 14 Jul 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. This study is not recruiting at the moment.
Shari Damast, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tapered applicator and Standard applicator in people with Endometrial Cancer and Brachytherapy, run by Yale University at 1 site in United States.
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 0 inclusion and 4 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 14 Jul 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 United States. 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?
Patient comfort (time frame: up to 10 minutes). The study lists 2 primary outcomes in all. 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 Jul 2023.