A Novel Tapered Applicator for Vaginal Vault Brachytherapy

Not Applicable

Completed

• Conditions: Endometrial Cancer; Quality of Life; Brachytherapy
• Interventions: Other: Standard applicator; Other: Tapered applicator

• Registration Number: NCT04318340
• Lead Sponsor: Yale University

Brief 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.

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 Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-23
• Study Start: 2020-07-16
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard Applicators	Standard applicator	All patients will be fitted with the 2.6 cm applicator and sized up to the 3.0 cm applicator if tolerable.
Tapered Applicator	Tapered applicator	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.

Primary Outcome Measures

Name	Time	Method
Patient comfort	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	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.

Secondary Outcome Measures

Name	Time	Method
Assess in vivo dosimetry (optional for all patients)	up to 10 minutes	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.

Trial Locations

Locations (1)

Smilow Cancer Hospital; 🇺🇸 New Haven, Connecticut, United States