Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

NCT06007027 | Recruiting DMC

• 1 other identifier: VagLaser
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This project will be based on three studies over a period on three years. The first study is a dose response study that includes 30 breast cancer survivors. They will receive a total of 5 laser treatments with 4-6 weeks intervals The second study is a double-blind randomized controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active intervention and 30 will receive placebo laser treatment and act as controls. Based on the results of the dose response study, a treatment consists of three to five laser treatments every 3 weeks. The third and last study is a one-year follow-up on study two. The conditions are evaluated before and after each treatment by questionnaires, vaginal fluid pH values, punch biopsies and vaginal and urine microbiome. The studies is conducted at the Department of Obstetrics and Gynaecology at Randers Regional Hospital in collaboration with Department of Obstetrics and Gynaecology and Department of Oncology at Aarhus University Hospital.

Conditions

Genitourinary Syndrome of Menopause

Keywords

laser; mamma cancer

Outcome Measures

Primary Outcomes (1)

• Vaginal dryness

  Participant are asked to complete the 10-cm visual analog scale (VAS) ranging for 0 to 10, with higher score indicating worse vaginal dryness.

  Symptom data is collected at baseline visit and one month after the last treatment

Secondary Outcomes (8)

• Change in vaginal pain, itching and soreness

  Symptom data is collected at baseline visit and one month after the last treatment

• Female Sexual Function Index

  Symptom data is collected at baseline visit and one month after the last treatment

• Sexual complaint screener - women

  Symptom data is collected at baseline visit and one month after the last treatment

• Urogenital Distress Inventory

  Symptom data is collected at baseline visit and one month after the last treatment

• International Consultation on Incontinence Questionnaire Female Urinary Tract Symptoms Sex

  Symptom data is collected at baseline visit and one month after the last treatment

Study Arms (2)

Active laser group

EXPERIMENTAL

In the active laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, MonaLisa Touch, DEKA, Florence, Italy), using the following setting; dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μs and the smart stack parameter from 2 to 3. At the level of the vaginal introitus, the dot power decreases to 20 Watt.

Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy

Sham laser group

SHAM COMPARATOR

In the sham laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy), using the following setting; dot power 0,5 watt, dwell time 100 μs, dot spacing 2000 μs and the smart stack parameter from 1 to 1

Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy

Interventions

SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy DEVICE

The laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.

Active laser group; Sham laser group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer survivor in endocrine therapy
• Symptomatic genitourinary symdrom of menopause with vaginal discomfort and/or dyspareunia
• Able to read and understand Danish
• Able to give written informed consent

You may not qualify if:

• Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification staging system
• Use of non-hormonal/hormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively)
• Use of Chemotherapy (6 months prior to the baseline visit)
• Acute urinary tract infection or active genital infection
• History of vaginal reconstructive surgery

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Obstetrics and Gynaecology, Randers Regional Hospital

Randers, 8930, Denmark

RECRUITING

Related Publications (1)

• Jacobsen S, Glavind-Kristensen M, Jensen AB, Forman A, Bor P. Vaginal CO2 laser therapy for genitourinary syndrome in breast cancer survivors-VagLaser study protocol: a randomized blinded, placebo-controlled trial. BMC Cancer. 2023 Nov 29;23(1):1164. doi: 10.1186/s12885-023-11656-x.

  PMID: 38031020 DERIVED

Central Study Contacts

Sine Jacobsen, MD

CONTACT

+4578421069; sinjac@rm.dk

Pinar Bor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 23, 2023
• Study Start: December 1, 2024
• Primary Completion: January 30, 2026
• Study Completion: March 30, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

DK (1)