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Fractional CO2 Laser Therapy Versus 4% Topical Lidocaine Gel for Dyspareunia in Breast Cancer Survivors (BCLS)

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ClinicalTrials.gov Identifier: NCT03257670
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Syneron Candela
Information provided by (Responsible Party):
James Whiteside, University of Cincinnati

Brief Summary:
This trial seeks to determine if therapy with a CO2 laser to the vagina is more effective than lidocaine to the opening of the vagina before intercourse to reduce painful intercourse in women who are breast cancer survivors. This study will also be looking at whether or not the CO2 laser improves pelvic floor function, bowel and bladder function, and sexual function before and after treatment.

Condition or disease Intervention/treatment Phase
Dyspareunia Drug: 4% Topical Lidocaine Gel Device: CO2RE fractional laser therapy Not Applicable

Detailed Description:

This is a randomized trial to determine the comparative effectiveness of the CO2RE laser device relative to topical lidocaine in treating dyspareunia among breast cancer survivors. The large and growing population of breast cancer survivors experience a significant burden of urogenital symptoms including dyspareunia. Several studies have evaluated the feasibility and effectiveness of CO2 lasers for the treatment of symptomatic vulvovaginal atrophy in postmenopausal women suggesting improvements in atrophy symptoms with favorable histological and microscopic changes. There is little know about the effectiveness of CO2 laser therapy in breast cancer survivors.

Patients who are breast cancer survivors experiencing dyspareunia and desiring intervention will be randomized to two cohorts: (1) Treatment with the CO2RE laser or (2) application of 4% aqueous lidocaine applied to the vulvar vestibule for 3 minutes before vaginal penetration. The primary outcome will be the overall as well as lubrication, satisfaction, and pain domain scores on the Female Sexual Function Index instrument. Secondary outcomes will be according to other validated pain and pelvic floor symptom instruments.

Following initiation of treatment, both groups will follow up at one-week, 1-month, 3-months, and 6-months. At the 3-month assessment, subjects in the lidocaine arm will be given the option to undergo CO2RE laser therapy. A combination of validated and non-validated physical exam and survey instruments will be utilized at each visit in order to assess pelvic floor function, bowel and bladder function, and sexual function before and after treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to two treatment cohorts (each with 35 patients): (1) treatment with the CO2RE laser or; (2) treatments of 4% aqueous lidocaine applied to the vulvar vestibule for 3 minutes before vaginal penetration. Both cohorts will have four follow-up assessments following initiation of treatment: (1) One-week post treatment initiation; (2) 1-month post treatment initiation; (3) 3-months post treatment initiation and; (4) 6-months post laser-only treatment initiation. At the 3-month assessment, subjects in the lidocaine arm will be allowed to try the CO2RE laser therapy. In doing this, an imbedded crossover trial is included that will allow assessment of subject decision-satisfaction between the two therapy approaches. The primary outcome will be the overall and lubrication, satisfaction, and pain domain scores on the Female Sexual Function Index instrument. Secondary outcomes will be other validated pain and pelvic floor symptom instruments.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing Treatment of Dyspareunia With Fractional CO2 Laser Therapy Versus 4% Topical Lidocaine Gel in the Setting of Breast Cancer Survivors.
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : November 1, 2018


Arm Intervention/treatment
Active Comparator: CO2RE Laser
This group will undergo vaginal CO2 laser therapy for a total of three (3) treatments with one month between treatments.
Device: CO2RE fractional laser therapy
This group will undergo vaginal CO2 laser therapy for a total of three (3) treatments with one month between treatments.

Active Comparator: 4% Topical Lidocaine Gel
This group will be given 4% topical lidocaine gel to take home. The patient will apply the 4% lidocaine gel to the outside and opening of the vagina for 3 minutes before vaginal penetration. The patient will continue using the numbing gel prior to vaginal penetration for the extent of the study (3 months).
Drug: 4% Topical Lidocaine Gel
This group will be given 4% topical lidocaine gel to take home. The patient will apply the 4% lidocaine gel to the outside and opening of the vagina for 3 minutes before vaginal penetration. The patient will continue using the numbing gel prior to vaginal penetration for the extent of the study (3 months).




Primary Outcome Measures :
  1. Female Sexual Function Index (FSFI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia. [ Time Frame: 9 months ]

    The Female Sexual Function Index (FSFI) is a survey instrument used to determine the level of sexual function or dysfunction in females. It is comprised of a 19 item questionnaire focused on sexual functioning. There are six domains assessed: desire, arousal, lubrication, orgasm, satisfaction, and pain. The subject is to consider each of the questions in the context of the previous 4 weeks. The scores of each of the domains are then calculated into a final score.

    Initial and follow-up assessments will allow comparisons across this instrument as well as all the secondary and other pre-specified outcome measures.



Secondary Outcome Measures :
  1. Numeric Pain Rating Scale (NPRS) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia. [ Time Frame: 9 months ]
    The Numeric Pain Rating Scale (NPRS) is a measure of pain intensity in adults.The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion. Scores range from 0-10 with higher numbers representing higher pain intensity.

  2. Incontinence Severity Index (ISI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia. [ Time Frame: 9 months ]
    The Incontinence Severity Index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into none, slight, moderate, severe, and very severe. It assess the frequency (from 0-4): (0-never, 1-less than once a month, 2-a few times a month, 3-a few times a week, 4-every day and/or night ), and amount (from 0-3) of urine leakage: 0-none, 1-drops, 2-small splashes, 3-more. The index value is from 0-12 obtained by multiplying the numbers responded in the two questions with categories of urinary incontinence severity of: None (0), Slight (1-2), Moderate (3-6), Severe (8-9), Very severe (12).

  3. 3 Incontinence Questions (3-IQ) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia. [ Time Frame: 9 months ]
    The 3 Incontinence Questions (3-IQ) is a survey instrument that is used to determine if a patient has stress urinary incontinence (SUI), urge urinary incontinence (UUI), or mixed urinary incontinence (MUI). The subject is to consider each of the questions in the context of the previous 3 months.The first question asks if the patient has every leaked urine. The second question asks the patient to indicate if she has leaked urine with any of the following: activity, urge, or without activity or urge. The Third question asks which form of urinary leakage was most common. The response to question 3 is then used to determine if the patient has: 1) Stress only or mostly stress, 2) urge only or mostly urge, 3) other cause, or 4) mixed.

  4. Colon Rectal Anal Distress Inventory (CRADI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia. [ Time Frame: 9 months ]
    The Colon Rectal Anal Distress Inventory (CRADI) is a survey instrument used to determine the level and severity of bowel symptoms. It consists of 17 questions inquiring to specific questions regarding bowel symptoms. Total score out of 400, with higher scores indicating more bowel symptoms.

  5. Patient Global Impression of Severity (PGI-S) score before treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia. [ Time Frame: 9 months ]
    The PGI-S are 1 question assessments of overall condition severity before implementation of therapy measured on a 7-point response scale.

  6. Patient Global Impression of Improvement (PGI-I) score after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia. [ Time Frame: 9 months ]
    The Patient Global Impression of Improvement (PGI-I) is 1 question assessment of overall condition improvement since implementation of therapy measured on a 7-point response scale.

  7. Satisfaction with Decision (SDS) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia. [ Time Frame: 9 months ]
    The Satisfaction with Decision (SDS) was developed to measure patient satisfaction with health care decisions. The SDS is a 6-item questionnaire with a 5-point response scale with higher scores indicating higher overall satisfaction.


Other Outcome Measures:
  1. Symptom inventory (number of voids/day, pads/day, etc.) [ Time Frame: 9 months ]
    Symptom inventory (number of voids/day, pads/day, etc.) will be collected and available for comparison by cohort prior to and after treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Subjects must be female who have undergone treatment for breast cancer that have dyspareunia secondary to the treatment they received for breast cancer.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects included must be female breast cancer survivors over the age of 18, sexually active (at least 4 episodes of sexual intercourse per month), and find intercourse painful. Subjects must also be English speaking and able to give informed consent.

Exclusion Criteria:

  • Subjects will be excluded if pregnant, has not had breast cancer, does not have painful intercourse secondary to treatment received for their breast cancer, is not English speaking, or lacks the ability to sign informed consent.

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): NCT03257670


Contacts
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Contact: James L Whiteside, MD 513-475-8713 whitesje@ucmail.uc.edu
Contact: Carson T Kaeser, MD 513-475-8713 carson.kaeser@thechristhospital.com

Locations
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United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: James L Whiteside, MD    513-475-8713    whitesje@ucmail.uc.edu   
Contact: Carson T Kaeser, MD    513-585-3474    carson.kaeser@thechristhospital.com   
Principal Investigator: James L Whiteside, MD         
Sub-Investigator: Jamie D Lewis, MD         
Sub-Investigator: Carson T Kaeser, MD         
Sub-Investigator: Cynthia Dehlinger, CNM         
Sponsors and Collaborators
University of Cincinnati
Syneron Candela
Investigators
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Principal Investigator: James L Whiteside, MD University of Cincinnati

Publications:

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Responsible Party: James Whiteside, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03257670     History of Changes
Other Study ID Numbers: UC Laser
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by James Whiteside, University of Cincinnati:
Dyspareunia
Laser
CO2
Breast Cancer
Vaginal Atrophy
Lidocaine
Additional relevant MeSH terms:
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Dyspareunia
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Mental Disorders
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action