Laser Therapy Following Radiotherapy for Gynecological Cancer

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Prisijungti Registracija

Nuoroda įrašoma į mainų sritį

StatusasVerbavimas

Rėmėjai

National and Kapodistrian University of Athens

KLINIKINIS TYRIMAS: NCT03714581

BioSeek: NCT03714581

Raktažodžiai

vėžys

Santrauka

Women with a history of pelvic radiotherapy due to gynecological cancer, will receive laser therapy for the management of genitourinary syndrome of menopause.

Datos

Paskutinį kartą patikrinta:	06/30/2019
Pirmasis pateikimas:	10/13/2018
Numatytas registravimas pateiktas:	10/17/2018
Pirmas paskelbtas:	10/21/2018
Paskutinis atnaujinimas pateiktas:	07/27/2019
Paskutinis atnaujinimas paskelbtas:	07/29/2019
Faktinė studijų pradžios data:	11/14/2018
Numatoma pirminio užbaigimo data:	05/31/2021
Numatoma studijų užbaigimo data:	05/31/2021

Būklė ar liga

Pelvic Radiotherapy

Gynecological Cancer

Dyspareunia

Vaginal Dryness

Intervencija / gydymas

Device: Microablative Fractional CO2 Laser Therapy

Fazė

Rankų grupės

Ranka	Intervencija / gydymas
Experimental: Laser 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 Comparator: Placebo 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.

Tinkamumo kriterijai

Tinkamos studijoms lytys

Female

Priima sveikus savanorius

Taip

Kriterijai

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)

Rezultatas

Pirminės rezultatų priemonės

1. 10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness [Change from baseline at 1 month post-treatment]

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

Antrinės rezultatų priemonės

1. 3 days voiding diary [Change from baseline at 1 month post-treatment]

Assesses frequency of urination, amount of urine, presence of urgency and/or urinary incontinence and amount of fluid intake

2. Day-to Day Impact of vaginal aging questionnaire (DIVA) [Change from baseline at 1 month post-treatment]

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

3. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ) cervical cancer module (CX24) [Change from baseline Quality of Life questionnaire (QLQ) cervical cancer module (CX24) at 1-month post-treatment]

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

4. Patients Global Impression of Improvement [At 1-month post-treatment]

It is a single item questionnaire assessing the impression of participants following the intervention

5. International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS) [Change from baseline International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS) at 1-month post-treatment]

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.

6. King's Health Questionnaire (KHQ) [Change from baseline King's Health Questionnaire at 1-month post-treatment]

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.

7. Female Sexual Function Index [Change from baseline Female Sexual Function Index at 1-month post-treatment]

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

8. Vaginal Maturation Value [Change from baseline Vaginal Maturation Value at 1-month post-treatment]

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.

9. Vaginal Health Index Score [Change from baseline Vaginal Health Index Score at 1-month post-treatment]

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.

10. Partner Performance Questionnaire [Change from baseline Partner Performance Questionnaire at 1-month post-treatment]

It evaluates aspects of sexual satisfaction of cancer survivors partners