Sexual and Vaginal Health in Breast Cancer Women Receiving Aromatase Inhibitors Before and After CO2 Laser Therapy

NCT04619485 | Unknown

• 1 other identifier: HCB/2019/0786
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Vulvovaginal health, directly linked to sexual health, is a key factor for female pleasure. BCS receiving AI are likely to present severe GSM and sexual complaints. Innovative options, as vaginal laser therapy, are emerging to treat GSM and sexual dysfunctions. Nowadays, data in BCS is scarce, moreover, few studies included patients receiving AI \[16\]. Different meta-analysis \[17-23\] found GSM \[24, 25\] and sexual function \[9, 10\] may improve significantly at short-term, however, the body of evidence is of low quality. Therefore, before recommendation of laser therapy for sexual complaints in BCS with GSM, there are unmet needs to be solved: efficacy and safety at long-term, biases related to patients' expectations and a detailed assessment of the complex underpinnings of sexuality. Aims: To evaluate sexual and vaginal health in BCS receiving AI with GSM, before and after CO2 laser therapy compared to a sham-controlled group. Methods: Prospective, randomized, double-blind controlled study with two parallel study arms: 1) Fractional CO2 laser therapy (5monthly sessions). 2) Sham laser therapy (5monthly sessions). After end-treatment, patients are followed up at 1 month and 6 months. BCS treated or undergoing AI with GSM and sexual function impairment, will be suitable. All patients will maintain first-line non-hormonal treatment and sexual assessment (PLISSIT Model) according with usual care. The primary outcome is improvement in sexual function (FSFI total score). As secondary outcomes: resumption sexual activity, sexual activity frequency, dyspareunia (VAS), female sexual dysfunction, sexual dimensions (FSFI), body image (S-BIS), quality of life (SF-12), vaginal pH acidification, maturation index and Vaginal Health Index of Gloria Backmann, adverse events, satisfaction (Likert scale) and adherence to treatment. Expected impact: Emergent, non-invasive, laser therapy has significant benefit for BCS with AI, improving subjective and objective sexual and vaginal health outcomes and adding value to the usual care multidisciplinary approach.

Conditions

Breast Cancer; Genitourinary Syndrome of Menopause

Keywords

BREAST CANCER; Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (1)

• Female Sexual Function Index (FSFI)

  The 19 items of the FSFI use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual functioning on the respective item. To score the measure, the sum of each domain score is first multiplied by a domain factor ratio (0.6 for desire; 0.3 for arousal; 0.3 for lubrication; 0.4 for orgasm; 0.4 for satisfaction; and 0.4 for pain) in order to place all domain totals on a more comparable scale, and then subsequently summed to derive a total FSFI score.

  12 months

Secondary Outcomes (7)

• Vaginal pH

  12 months

• Vaginal epithelium thickness

  12 months

• Resumption of sexual activity

  12 months

• Sexual activity frequency

  12 months

• Dyspareunia

  12 months

Study Arms (2)

SHAM LASER

SHAM COMPARATOR

Group A: Arm using basal treatment and adding vaginal laser using double blind to adjust the treatment to zero potence.

Device: CO2 SHAM LASER

EFFECTIVE LASER

ACTIVE COMPARATOR

Group B: Arm using basal treatment and adding vaginal laser using double blind to adjust the treatment to regular potence.

Device: CO2 LASER

Interventions

CO2 LASER DEVICE

5 SESSIONS OF CO2 VAGINAL LASER

EFFECTIVE LASER

CO2 SHAM LASER DEVICE

5 SESSIONS OF CO2 VAGINAL SHAM LASER

SHAM LASER

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BC treated with aromatase inhibitors ± GnRH analogues (aGnRH)
• Menopause (natural or induced) and signs / symptoms of GSM
• Vaginal pH ≥5
• Negative Human Papillomavirus (HPV) cytology and / or determination
• Intention or willingness to have sex
• Signed informed consent

You may not qualify if:

• Vaginal hormonal treatment in the last 6 months
• Vaginal moisturizers and / or lubricants during the 30 days prior to study treatment
• Laser treatment, radiofrequency, hyaluronic acid, lipofilling in the vagina during the last 2 years
• Ospemifene treatment
• Being affected for: active infection of the genital tract; intraepithelial neoplasm of cervix, vagina, or vulva; have or have been treated for genital cancer
• Genital prolapse stage ≥II.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Eduard Mension Coll

Barcelona, 08036, Spain

Location

Related Publications (1)

• Mension E, Alonso I, Angles-Acedo S, Ros C, Otero J, Villarino A, Farre R, Saco A, Vega N, Castrejon N, Ordi J, Rakislova N, Tortajada M, Matas I, Gomez S, Ribera L, Castelo-Branco C. Effect of Fractional Carbon Dioxide vs Sham Laser on Sexual Function in Survivors of Breast Cancer Receiving Aromatase Inhibitors for Genitourinary Syndrome of Menopause: The LIGHT Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255697. doi: 10.1001/jamanetworkopen.2022.55697.

  PMID: 36763359 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Immaculada Alonso Vargas

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: randomized, double-blind, sham-controlled trial

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: October 30, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

ES (1)