Back to resultsLaser Therapy Following Radiotherapy for Gynecological Cancer
Primary Purpose
Pelvic Radiotherapy, Gynecological Cancer, Dyspareunia
Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Microablative Fractional CO2 Laser Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Radiotherapy
Eligibility Criteria
Inclusion Criteria:
- History of gynecological cancer treated with pelvic radiotherapy
- last radiotherapy >1 year
- women sexually active or willing to resume sexual activity
- symptoms of dyspareunia, vaginal dryness, itching/burning and vaginal bleeding related to sexual intercourse
Exclusion Criteria:
- Relapse of gynecological cancer
- prolapse stage >1
- active genital infection (i.e herpes, vaginitis)
- underlying pathologies that could interfere with patients compliance to the protocol (i.e any psychiatric condition)
Sites / Locations
- Urogynecological Unit of Alexandra HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Laser
Placebo
Arm Description
Microablative Fractional CO2 Laser Therapy (The parameters that will be used are the following: 1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.)
Placebo therapy (The parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.
Outcomes
Primary Outcome Measures
10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness
It is a straight line with 2 endpoints "0" and "10". Zero defines "no dyspareunia at all" and "no dryness at all" , while 10 "dyspareunia as bad as it could be" and "dryness as bad as it could be". Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of dyspareunia and dryness
Secondary Outcome Measures
3 days voiding diary
Assesses frequency of urination, amount of urine, presence of urgency and/or urinary incontinence and amount of fluid intake
Day-to Day Impact of vaginal aging questionnaire (DIVA)
It includes 4 domains: activities of daily living (5 items), sexual functioning (5 items), emotional well-being (4 items), self-concept and body image (5-items). Each item of each domain could receive values from 0 to 4. Mean scores are calculated on each of the domain scales. Higher scores indicate greater symptom impact
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ) cervical cancer module (CX24)
It includes 4 functional scales (body image, sexual activity, sexual enjoyment, sexual/vaginal functioning) with 9 items and 5 symptoms scales (symptoms experience, lymphedema, peripheral neuropathy, menopausal symptoms and sexual worry) with 15 items. Each item range from 1 to 4. Higher scores in sexual activity and sexual enjoyment indicate better functioning, while higher scores in all other domains indicate higher impact of cervical cancer
Patients Global Impression of Improvement
It is a single item questionnaire assessing the impression of participants following the intervention
International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS)
It is a 12-items questionnaire evaluating nocturia, urgency, bladder pain, frequency, hesitancy, straining, intermittency, urinary incontinence (urge, stress and unexplained), frequency of urinary incontinence and nocturnal enuresis. Filling, voiding and incontinence symptoms subscales range from 0 to 15, 0 to 12 and 0 to 20, respectively.
King's Health Questionnaire (KHQ)
It has 3 sections: 1) general health and overall health related to urinary symptoms with 2 questions, 2) incontinence impact, role limitations, physical limitations, social limitations, personal limitations, emotions, sleep and energy, and severity coping measures with 19 questions and 3) bother or impact of urinary symptoms with 11 questions. Scores of each domain of the 2 sections range from 0 to 100. Scores of the third section range from 0 to 3. Higher scores indicate higher impact of urinary incontinence.
Female Sexual Function Index
It includes 6 domains assessing sexual functioning (desire, arousal, orgasm, lubrication, satisfaction and pain). Total score is calculated by summing scores of the 5 domains multiplied by certain factors with a minimum value of 2 and maximum 36
Vaginal Maturation Value
It is calculated by defining the percentage of superficial, intermediate and parabasal epithelial cells on the vaginal pap smear, following the formula (1x%superficial)+(0.5x%intermediate)+(0x%parabasal). It may receive values from 0 to 100%.It is considered to be an indicator of the estrogenic stimulation, whereas values of 0-49%, 50-64% and 65-100% indicate absent/low, moderate and high estrogenic effect on the vaginal epithelium, respectively.
Vaginal Health Index Score
It evaluates vaginal elasticity, fluid volume, ph of vaginal fluid, epithelial integrity and moisture. Each one of these may receive scores from 1 to 5. Total score is calculated by summing the 5 scores ranging from 5 to 25. Higher scores indicate better vaginal status.
Partner Performance Questionnaire
It evaluates aspects of sexual satisfaction of cancer survivors partners
Full Information
NCT ID
NCT03714581
First Posted
October 14, 2018
Last Updated
July 28, 2019
Sponsor
National and Kapodistrian University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT03714581
Brief Title
Laser Therapy Following Radiotherapy for Gynecological Cancer
Official Title
The Efficacy of Intravaginal Laser Therapy in Women With History of Gynecological Cancer Treated With Pelvic Radiotherapy: Double-blind Randomized Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Women with a history of pelvic radiotherapy due to gynecological cancer, will receive laser therapy for the management of genitourinary syndrome of menopause.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Radiotherapy, Gynecological Cancer, Dyspareunia, Vaginal Dryness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laser
Arm Type
Experimental
Arm Description
Microablative Fractional CO2 Laser Therapy (The parameters that will be used are the following: 1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo therapy (The parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.
Intervention Type
Device
Intervention Name(s)
Microablative Fractional CO2 Laser Therapy
Other Intervention Name(s)
SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy
Intervention Description
5 laser therapies intravaginally administered will be applied at monthly intervals.
Primary Outcome Measure Information:
Title
10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness
Description
It is a straight line with 2 endpoints "0" and "10". Zero defines "no dyspareunia at all" and "no dryness at all" , while 10 "dyspareunia as bad as it could be" and "dryness as bad as it could be". Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of dyspareunia and dryness
Time Frame
Change from baseline at 1 month post-treatment
Secondary Outcome Measure Information:
Title
3 days voiding diary
Description
Assesses frequency of urination, amount of urine, presence of urgency and/or urinary incontinence and amount of fluid intake
Time Frame
Change from baseline at 1 month post-treatment
Title
Day-to Day Impact of vaginal aging questionnaire (DIVA)
Description
It includes 4 domains: activities of daily living (5 items), sexual functioning (5 items), emotional well-being (4 items), self-concept and body image (5-items). Each item of each domain could receive values from 0 to 4. Mean scores are calculated on each of the domain scales. Higher scores indicate greater symptom impact
Time Frame
Change from baseline at 1 month post-treatment
Title
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ) cervical cancer module (CX24)
Description
It includes 4 functional scales (body image, sexual activity, sexual enjoyment, sexual/vaginal functioning) with 9 items and 5 symptoms scales (symptoms experience, lymphedema, peripheral neuropathy, menopausal symptoms and sexual worry) with 15 items. Each item range from 1 to 4. Higher scores in sexual activity and sexual enjoyment indicate better functioning, while higher scores in all other domains indicate higher impact of cervical cancer
Time Frame
Change from baseline Quality of Life questionnaire (QLQ) cervical cancer module (CX24) at 1-month post-treatment
Title
Patients Global Impression of Improvement
Description
It is a single item questionnaire assessing the impression of participants following the intervention
Time Frame
At 1-month post-treatment
Title
International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS)
Description
It is a 12-items questionnaire evaluating nocturia, urgency, bladder pain, frequency, hesitancy, straining, intermittency, urinary incontinence (urge, stress and unexplained), frequency of urinary incontinence and nocturnal enuresis. Filling, voiding and incontinence symptoms subscales range from 0 to 15, 0 to 12 and 0 to 20, respectively.
Time Frame
Change from baseline International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS) at 1-month post-treatment
Title
King's Health Questionnaire (KHQ)
Description
It has 3 sections: 1) general health and overall health related to urinary symptoms with 2 questions, 2) incontinence impact, role limitations, physical limitations, social limitations, personal limitations, emotions, sleep and energy, and severity coping measures with 19 questions and 3) bother or impact of urinary symptoms with 11 questions. Scores of each domain of the 2 sections range from 0 to 100. Scores of the third section range from 0 to 3. Higher scores indicate higher impact of urinary incontinence.
Time Frame
Change from baseline King's Health Questionnaire at 1-month post-treatment
Title
Female Sexual Function Index
Description
It includes 6 domains assessing sexual functioning (desire, arousal, orgasm, lubrication, satisfaction and pain). Total score is calculated by summing scores of the 5 domains multiplied by certain factors with a minimum value of 2 and maximum 36
Time Frame
Change from baseline Female Sexual Function Index at 1-month post-treatment
Title
Vaginal Maturation Value
Description
It is calculated by defining the percentage of superficial, intermediate and parabasal epithelial cells on the vaginal pap smear, following the formula (1x%superficial)+(0.5x%intermediate)+(0x%parabasal). It may receive values from 0 to 100%.It is considered to be an indicator of the estrogenic stimulation, whereas values of 0-49%, 50-64% and 65-100% indicate absent/low, moderate and high estrogenic effect on the vaginal epithelium, respectively.
Time Frame
Change from baseline Vaginal Maturation Value at 1-month post-treatment
Title
Vaginal Health Index Score
Description
It evaluates vaginal elasticity, fluid volume, ph of vaginal fluid, epithelial integrity and moisture. Each one of these may receive scores from 1 to 5. Total score is calculated by summing the 5 scores ranging from 5 to 25. Higher scores indicate better vaginal status.
Time Frame
Change from baseline Vaginal Health Index Score at 1-month post-treatment
Title
Partner Performance Questionnaire
Description
It evaluates aspects of sexual satisfaction of cancer survivors partners
Time Frame
Change from baseline Partner Performance Questionnaire at 1-month post-treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
History of gynecological cancer treated with pelvic radiotherapy
last radiotherapy >1 year
women sexually active or willing to resume sexual activity
symptoms of dyspareunia, vaginal dryness, itching/burning and vaginal bleeding related to sexual intercourse
Exclusion Criteria:
Relapse of gynecological cancer
prolapse stage >1
active genital infection (i.e herpes, vaginitis)
underlying pathologies that could interfere with patients compliance to the protocol (i.e any psychiatric condition)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stavros Athanasiou, Associate Professor
Phone
+306944478555
Email
stavros.athanasiou@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eleni Pitsouni, MD, MSc
Phone
+306976829710
Email
elinapitsouni@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavros Athanasiou, Associate Proffesor
Organizational Affiliation
National and Kapodistrian University of Athens, Greece
Official's Role
Study Director
Facility Information:
Facility Name
Urogynecological Unit of Alexandra Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stavros Athanasiou, Associate professor
Phone
+306944478555
Email
stavros.athanasiou@gmail.com
First Name & Middle Initial & Last Name & Degree
Themos Grigoriadis, Assistant Professor
Phone
+306948741306
Email
tgregos@yahoo.com
First Name & Middle Initial & Last Name & Degree
Stavros Athanasiou, Prof.
First Name & Middle Initial & Last Name & Degree
Themos Grigoriadis, Assist. Prof.
First Name & Middle Initial & Last Name & Degree
Eleni Pitsouni, MD,MSc
12. IPD Sharing Statement
Citations:
PubMed Identifier
31474161
Citation
Athanasiou S, Pitsouni E, Grigoriadis T, Michailidis G, Tsiveleka A, Rodolakis A, Loutradis D. A study protocol of vaginal laser therapy in gynecological cancer survivors. Climacteric. 2020 Feb;23(1):53-58. doi: 10.1080/13697137.2019.1646720. Epub 2019 Sep 2.
Results Reference
derived
Learn more about this trial
Laser Therapy Following Radiotherapy for Gynecological Cancer
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