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A Novel Tapered Applicator for Vaginal Vault Brachytherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318340
Recruitment Status : Not yet recruiting
First Posted : March 23, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Brachytherapy Quality of Life Other: Tapered applicator Other: Standard applicator Not Applicable

Detailed Description:

IIn 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Novel Tapered Applicator for Post-Hysterectomy Vaginal Vault Brachytherapy: Quality-of-Life Assessment of Patient Comfort and In Vivo Dosimetry
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : March 2024

Arm Intervention/treatment
Active Comparator: Standard Applicators
All patients will be fitted with the 2.6 cm applicator and sized up to the 3.0 cm applicator if tolerable.
Other: Standard applicator
A 2.6 cm standard applicator is inserted and sized up to a standard 3 cm applicator if tolerable.

Experimental: 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.
Other: Tapered applicator
An applicator inserted in 2 steps that tapers at the distal vagina




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Assess in vivo dosimetry (optional for all patients) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria

  • Patients with stage I-IV endometrial cancer.
  • Patient must have been treated with hysterectomy.
  • A radiation oncology determined the patient's disease warrants adjuvant treatment with vaginal brachytherapy as sole adjuvant radiotherapy.
  • Patient consented to receive standard of care vaginal brachytherapy treatment.
  • Vaginal cuff deemed healing appropriately by treating radiation oncologist during initial consultation without evidence of infection, pelvic symptoms, or other surgical complications.
  • 18 ≤ Age
  • English speaking.

Exclusion Criteria

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318340


Contacts
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Contact: Shari Damast, MD (203) 200-2635 shari.damast@yale.edu
Contact: Jennifer Pope 203-737-5801 jennifer.pope@yale.edu

Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Shari Damast, MD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04318340    
Other Study ID Numbers: 2000026385
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female