Item from the World Health Organization trial registration data set
Data category | Information |
Primary registry and trial identifying number | ClinicalTrials.gov: NCT06007027 |
Date of registration in primary registry | 22 August, 2023 |
Primary sponsor | Pinar Bor |
Secondary sponsors | Marianne Glavind-Kristensen and Anders Bonde Jensen |
Contact for public queries | Sine Jacobsen, MD, Mobile + 4560244277, Email sinjac@rm.dk |
Contact for scientific queries | Sine Jacobsen, MD Department of Obstetrics and Gynaecology, Randers Regional Hospital, Denmark Department of Clinical Medicine, Aarhus University, Denmark |
Public title | Vaginal CO2 laser therapy for genitourinary syndrome in breast cancer survivors |
Scientific title | Vaginal CO2 laser therapy for genitourinary syndrome in breast cancer survivors—A randomized blinded, placebo-controlled trial |
Country of recruitment | Denmark |
Health condition(s) or problem(s) studied | Genitourinary syndrome of menopause |
Intervention(s) | Active comparator: SmartXIDE2V2LR, MonaLisa Touch, DEKA, Florence, Italy (Setting: dot power 30 W, dwell time 1000 μs, dot spacing 1000 μs and the smart stack parameter from 2–3) Placebo comparator: SmartXIDE2V2LR, MonaLisa Touch, DEKA, Florence, Italy (Setting: 0 W, dwell time 100 μs, dot spacing 2000 μs and the smart stack parameter from 1 to 1) |
Key inclusion and exclusion criteria | Key inclusion criteria: Breast cancer survivor in endocrine therapy, age > 18 years, symptomatic genitourinary syndrome of menopause with vaginal discomfort and/or dyspareunia Key exclusion criteria: Use of non-hormonal/hormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively), treatment with Chemotherapy (6 months prior to the baseline visit) |
Study type | Interventional Allocation: randomized Intervention model: parallel assignment Masking: blinded (participants) Primary purpose: reducing late effects of breast cancer treatment |
Date of first enrolment | February 2023 |
Target sample size | 90 participants |
Recruitment status | Recruiting |
Primary outcome | Vaginal dryness |
Key secondary outcomes | Subjective outcomes are vaginal pain, itching, soreness, urinary symptoms and sexual function Objective outcomes are change in vaginal histology (punch biopsy), change in vaginal and urine microbiota and change in vaginal pH |
Background
Objectives
Methods
Site
Study period
Approval of the study protocol
Participants
Inclusion criteria: | Exclusion criteria: |
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Age > 18 years | Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification (POP-Q) staging system |
Breast cancer survivor in endocrine therapy | Use of non-hormonal vaginal therapies (1 month prior to the baseline visit) and use of hormonal vaginal therapy (12 months prior to the baseline visit) |
Symptomatic GDM with vaginal discomfort and/or dyspareunia | Treatment with chemotherapy (6 months prior to the baseline visit) |
Able to read and understand Danish | Acute urinary tract infection or active genital infection |
Able to give written informed consent | History of vaginal reconstructive surgery |
Vaginal CO2 laser protocol
Active treatment
Sham procedure used in the randomized study
Prohibited concomitant medications
Outcome measures
Primary outcome
Vaginal dryness
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Study I: Primary outcome is difference of vaginal dryness between baseline visit, and after third, fourth and fifth laser treatment.
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Study II: Primary outcome is difference in vaginal dryness four weeks after the last treatment between the laser group and the sham group.
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Study III: Primary outcome is vaginal dryness one year after the last laser treatment. Secondary outcome is the effect of one booster treatment on vaginal dryness.
Subjective secondary outcomes
Sexual function
Urinary symptoms
Vaginal health index (VHI)
Objective secondary outcomes
Change in vaginal pH
Change in vaginal histology
Change in vaginal and urine microbiota
Data collection
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Study I: Symptom data are collected at baseline, after each treatment visit and 6 months after the initial treatment. Vaginal biopsy is collected at baseline visit and 6 months after the initial treatment. Vaginal and urine microbiota are collected at baseline visit, at each treatment visit, and 6 months after initial treatment (Table 2).
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Study II: Symptom data, vaginal biopsy, vaginal and urine microbiota are collected at baseline visit and one month after the last treatment (Table 3).
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Study III: Symptom data, vaginal biopsy, vaginal and urine microbiota are collected at one year follow-up visit which is scheduled one year after the completion of the last treatment in the study II, and one month after the single "booster" treatment.
Baseline | Treatment no. 1 | Treatment no. 2 | Treatment no. 3 | Treatment no. 4 | Treatment no.5 | 4–6 weeks after 5.treatment | |
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Timepoint (weeks/months) | 0 weeks | 4 weeks | 8 weeks | 12 weeks | 16 weeks | 20 weeks | 6 months |
Eligibility criteria | x | ||||||
Informed consent | x | ||||||
Information from the patient record | x | ||||||
Questionnaires | x | x | x | x | |||
Gynaecological examination | x | x | x | x | x | x | |
Vaginal biopsy | x | x | |||||
Vaginal and urine Microbiota | x | x | x | x | x | x |
Baseline | Treatment no. 1 | Treatment no. 2 | Treatment no.3 | Treatment no.4/no. 5 | 4–6 weeks after the last treatment | |
---|---|---|---|---|---|---|
Timepoint (weeks/months) | 0 | 4 weeks | 8 weeks | 12 weeks | - | 4 months |
Eligibility criteria | x | |||||
Informed consent | x | |||||
Information from the patient record | x | |||||
Questionnaires | x | x | ||||
Gynaecological examination | x | x | ||||
Vaginal biopsy | x | x | ||||
Vaginal and urine Microbiota | x | x | x | x |