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Fractional CO2 Laser Therapy for Survivors of Breast Malignancies

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ClinicalTrials.gov Identifier: NCT03307044
Recruitment Status : Active, not recruiting
First Posted : October 11, 2017
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Allison Quick, Ohio State University Comprehensive Cancer Center

Brief Summary:
This pilot clinical trial studies how well fraction carbon dioxide (CO2) laser therapy works in treating vaginal atrophy in patients with breast cancer. Fraction CO2 laser therapy uses intense beams of light to cut, burn, or destroy tissue and may remodel vaginal tissue and direct controlled thermal damage of vaginal mucosa.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Cancer Survivor Cervical Carcinoma Dyspareunia Vaginal Dryness Procedure: Laser Therapy Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To demonstrate the feasibility of fractionated CO2 laser treatments in patients with breast cancer with vaginal atrophy by determining treatment completion rates and tolerability of treatment.

II. To demonstrate the efficacy of fractionated CO2 laser treatments in patients with breast cancer with vaginal atrophy as determined by improvement from baseline to post treatment in the score of the Vaginal Assessment Scale (VAS).

SECONDARY OBJECTIVES:

I. Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index (FSFI), and the Female Sexual Distress Scare (FSDS).

II. Other symptoms of urogenital atrophy using the Urogenital Distress Inventory (UDI).

III. Overall patient assessment of symptoms by Patient Global Impression of Improvement scale (PGI-I).

OUTLINE:

Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.

After completion of study treatment, patients are followed up at 4 weeks.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : December 21, 2018
Estimated Study Completion Date : January 29, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (fractional CO2 laser therapy)
Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.
Procedure: Laser Therapy
Undergo fractional CO2 laser therapy
Other Name: Therapy, Laser

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Change in Vaginal Assessment Scale score [ Time Frame: Baseline up to 4 weeks ]
    Using Vaginal Assessment Scale (VAS)

  2. Patient compliance rates [ Time Frame: Up to 4 weeks ]
    Compliance rates with treatment will be assessed.

  3. Feasibility of laser treatments defined by completion rates and tolerability of treatment [ Time Frame: Up to 4 weeks ]
    Will evaluate if laser can be completed and tolerated will be used to summarize demographics and clinical characteristics.


Secondary Outcome Measures :
  1. Other symptoms of urogenital atrophy using the Urogenital Distress Inventory [ Time Frame: Up to 4 weeks ]
    Descriptive statistics will be used to summarize demographics and clinical characteristics. Will either compare categorical responses from baseline to post treatment using McNemars Chi-square test or compare the change in response using a Signed Rank Test. Data will be transformed or a nonparametric test will be conducted if necessary.

  2. Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index, and the Female Sexual Distress Scare [ Time Frame: Up to 4 weeks ]
    Descriptive statistics will be used to summarize demographics and clinical characteristics. Will either compare categorical responses from baseline to post treatment using McNemar?s Chi-square test or compare the change in response using a Signed Rank Test. Data will be transformed or a nonparametric test will be conducted if necessary.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with non-metastatic breast cancer with any hormone receptor and Her 2 neu status who have completed surgery, chemotherapy, and radiation and are currently on endocrine therapy, single agent Herceptin, or observation
  • Symptoms of urogenital atrophy including dyspareunia or vaginal dryness

Exclusion Criteria:

  • Patients with metastatic breast cancer
  • Vaginal stenosis which would not allow vaginal probe to be placed (based on physician exam)
  • Active genital infection at the time of enrollment (if present initially, can be treated and then patient can be re-evaluated for eligibility)
  • Pelvic organ prolapse greater than stage II
  • Prior reconstructive pelvic surgery involving mesh
  • Hormone replacement therapy, vaginal estrogen therapy, DHEA, or biosynthetics within 6 weeks prior to enrollment

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): NCT03307044


Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Allison Quick, MD Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Allison Quick, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03307044     History of Changes
Other Study ID Numbers: OSU-17153
NCI-2017-01554 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Dyspareunia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Mental Disorders